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Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial
Abstract
Objective:
To investigate whether a 20-cc buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement.
Methods:
In a randomized, single-blind, placebo-controlled trial, women were assigned to receive either a 20-cc buffered 1% lidocaine paracervical block or no block before IUD placement. The primary outcome was pain with IUD placement measured on a 100-mm visual analog scale. Our sample size had 80% power (α=0.05) to detect a 20-mm difference in visual analog scale scores with a SD of 28 mm. Secondary outcomes included pain with speculum placement, paracervical block administration, tenaculum placement, 5 minutes postprocedure, and overall pain perception.
Results:
From October 7, 2014, through October 26, 2017, 64 women were enrolled and analyzed (33 in the paracervical block arm, 31 in the no-block arm). There were no differences in baseline demographics between the groups. Women who received the paracervical block reported less pain with IUD placement compared with women who received no block (median visual analog scale score of 33 mm vs 54 mm, P=.002). Pain was significantly less in the intervention group for uterine sounding (30 mm vs 47 mm, P=.005), 5 minutes after placement (12 mm vs 27 mm, P=.005), and overall pain perception (30 mm vs 51 mm, P=.015). Participants who received the paracervical block experienced more pain with block administration compared with placebo (30 mm vs 8 mm, P=.003). There was no perceived pain difference for speculum insertion (10 mm vs 6 mm, P=.447) or tenaculum placement (15 mm vs 10 mm, P=.268).
Conclusion:
A 20-cc buffered 1% lidocaine paracervical block decreases pain with IUD placement (primary outcome), uterine sounding (secondary outcome), and 5 minutes after placement (secondary outcome). Although paracervical block administration can be painful, perception of pain for overall IUD placement procedure is lower compared with no block.
Clinical trial registration:
ClinicalTrials.gov, NCT02219308.
... Similarly, 10% lidocaine spray improved discomfort during insertion in a non-invasive approach [18]. Another preparation of lidocaine in the form of a paracervical block was useful in pain reduction during and five minutes after placement it was also accompanied by pain during block administration [19]. While intramuscular ketorolac did not reduce pain during insertion, it decreased pain scores 15 minutes following it [20]. ...
... Table 1 reports the data on the pharmacological methods used. Seven out of 12 studies resulted in a significant decrease in pain on VAS values during IUD insertion: 10% lidocaine cervical spray [18], combination of two 50 mg diclofenac potassium oral tablets and 2% lidocaine cervical gel [22], a 5% cream mixture of 25 mg lidocaine and 25 mg prilocaine per gram of cream applied to the cervix [9], 20 mL 1% lidocaine paracervical block [19], 6 mL 2% lidocaine paracervical block [27], 20 mg ketorolac oral tablets [28], and vaginal tablets of 200 μg misoprostol and 3 mg dinoprostone [29]. The successful trials primarily involved applying medication directly to the cervix or using the medication within the vagina rather than systemically. ...
... Strangely, these drugs, lidocaine as a cervical gel and spray [30] and intramuscular ketorolac 30 mg [20], had reduced pain in other studies or other formulations. Additionally, not all trials that utilized paracervical blocks with lidocaine significantly reduced pain with IUD insertion [19,27,31]. ...
Intrauterine devices (IUDs) are considered a reliable contraceptive option for women, but they can come with side effects. There is a disconnect in standard guidelines for IUD insertion within and without the U.S. The objective of this review was to address a gap in the literature regarding official procedures for pain management during IUD implantation. This scoping review was initiated using keywords to extract relevant articles from multiple databases: U.S. National Library of Medicine National Institutes of Health (PubMed), MEDLINE (Ovid), and Excerpta Medica dataBASE (EMBASE, Ovid). Initially, 457 articles were identified and after a rigorous screening and selection process, 37 articles were chosen to be further assessed to ascertain if they met the study’s inclusion criteria. Those 37 articles were further evaluated fully to check for relevancy. From that process, 19 articles were chosen for the review, and all passed quality assessment evaluations using the JB Appraisal Tools. To best address the research question, the data from the 19 articles were divided into three categories: 1) circumstantial factors, 2) non-pharmacological methods, and 3) pharmacological methods. Circumstantially, women with previous vaginal deliveries experienced the lowest pain during the procedure, and nulligravid (never pregnant) women experienced the most pain. Lower pain scores were reported by lactating women compared to non-lactating. Black women experienced the most anticipated pain compared to other races. Regarding non-pharmacological methods, different insertion techniques, tools, and the use of a cold compress were found to not affect the level of pain during IUD insertion. Lastly, it was shown that pharmacological methods such as lidocaine gel, lidocaine paracervical block, and lidocaine combined with either diclofenac or prilocaine decreased pain scores at different time stamps of the procedure. Also, oral ketorolac and a vaginal combination of misoprostol and dinoprostone helped reduce pain. Findings from this scoping review revealed a lack of uniformity across practices when performing IUD insertions, possibly due to differences in procedures across circumstantial factors, non-pharmacological methods, and pharmacological methods. More research is needed to investigate the intricacies of pain with IUD insertion. Moving forward, especially following a potential increase in the use of IUDs after the reversal of Roe v. Wade, establishing this gap may lead to a more refined standardized protocol to mitigate pain with IUD insertions.
... A standard 10 cm visual analogue scale (VAS) for pain scoring was used in our trial which was the same as Karasahin et al. (19) trial, Aksoy et al. (14) trial, and Hubacher et al. (22) trial. This validated pain scale uses a 10 cm line to represent the continuum of 'no pain at 0' to 'worst imaginable pain at 10', on the other hand the Allen et al. (17) trial, Bednarek et al. (21) trial, Farala et al. (16) and Mody's et al. (10) trial used 1 to 100 pain scoring system, the same as standard VAS but numbered from 1 to 100 rather than from 1 to 10 with' no pain at l' and 'worst imaginable pain at 100'. ...
... Most of the previous studies on this topic had compared a single method with either a control group or placebo as seen in the studies of (14)(15)(16)(17)(18)(19)(20) ; however the aim of our study was to compare the effects of 3 different forms of topical lidocaine applied prior to IUCD insertion. ...
... Farala et al. (16) concluded that 20 cc 1% lidocaine paracervical block decreases pain with IUCD placement, uterine sounding ,5 minutes after placement and overall pain perception A total of 64 women were enrolled and analyzed (33 in the paracervical block arm, 31 in the no-block arm). Women who received the paracervical block reported less pain with IUCD placement compared with women who received no block (median visual analog scale score of 33 mm vs 54 mm, P=0.002). ...
... T he paracervical block is a widely used technique for pain management in gynecologic procedures. 1,2 Although a painful procedure in and of itself, with reported pain of 27-56 mm on a 100 mm visual analog scale (VAS), [3][4][5][6][7][8][9] paracervical block, when compared with a sham block, has been shown to decrease reported pain with various gynecologic procedures, including intrauterine device (IUD) insertion, 4,9 firsttrimester aspiration abortion, 3 and osmotic dilator insertion. 5 A 2009 survey of National Abortion Federation clinicians illustrated that, although paracervical block is nearly universal, the volume of anesthetic used for paracervical block in first-trimester abortion procedures significantly varies. ...
... This led to the wide adoption of the 20-mL, buffered 1% lidocaine paracervical block and additional studies of this paracervical block in other gynecologic procedures showing it was superior to placebo. 4,5 More recently, given the cost and inconvenience of a buffer, Chin et al 11 completed a randomized study comparing a 20-mL buffered, 1% lidocaine paracervical block to a nonbuffered, 1% lidocaine paracervical block and found no benefit to adding a sodium bicarbonate buffer to reduce pain with paracervical block. ...
... The remaining lidocaine was then injected into the cervicovaginal junction, at a depth of 1.5-2 cm, in two equal aliquots at 4 and 8 o'clock. [3][4][5][6][7][8] No wait time was required before insertion of osmotic dilators. 8 Procedures were performed by Complex Family Planning faculty and fellows or Obstetrics and Gynecology residents under faculty supervision. ...
Objective:
To evaluate whether a 12-mL paracervical block is noninferior to a 20-mL block in reducing pain with osmotic dilator insertion.
Methods:
In this single-blinded noninferiority trial, we randomized individuals undergoing insertion of osmotic dilators before second-trimester abortion to receive either a 12-mL or 20-mL 1% lidocaine paracervical block. The primary outcome was pain immediately after insertion of osmotic dilators. Prespecified secondary outcomes included pain with paracervical block administration, overall pain, and side effects, with 88 participants being required for a noninferiority margin of 15 mm on a 100-mm visual analog scale assuming an SD of 28. We analyzed data using Wilcoxon rank sum, χ2, and t tests and performed analysis of variance to account for repeated measures. Secondary analysis included multivariable regression to explore potential confounders.
Results:
From January 2018 to October 2020, of 232 eligible individuals, 174 were approached and 96 randomized (48 participants to each group); 91 were available for analysis (45: 12 mL, 46: 20 mL). Group demographics were similar, with a mean gestation of 21 weeks and four osmotic dilators placed. The 12-mL paracervical block was noninferior to the 20-mL paracervical block for pain with osmotic dilator insertion with a difference in means of -1.36 (95% CI -12.56 to 9.85) favoring 12 mL. Median pain scores after dilator placement were 47 mm (interquartile range 22-68) and 50 mm (interquartile range 27-67) in 12-mL compared with 20-mL paracervical block, respectively (P=.81). No difference was seen in median pain at baseline, with paracervical block administration, postprocedure or with overall pain or experience. At least one lidocaine-related side effect occurred in 4% of participants in the 12-mL group compared with 13% for those receiving 20 mL (P=.15), with metallic taste, ringing in ears, and lightheadedness being most common.
Conclusion:
A 12-mL paracervical block is noninferior to a 20-mL block for pain reduction with osmotic dilator insertion.
Clinical trial registration:
ClinicalTrials.gov, NCT03356145.
... 13e26 Local lidocaine injections appear to be effective in reducing pain during IUC insertion. 15,16,27,28 In these studies, the lidocaine dose used ranged from 100 to 200 mg, administered through a paracervical block. ...
... 14 Two studies of paracervical block at IUC insertion showed pain reduction in nulligravidas using higher doses of lidocaine (100 and 200 mg) than in our study (72 mg). 15,16 In 1 study, intracervical block with 36 mg of lidocaine was compared to 400 mg of oral ibuprofen in women without prior vaginal deliveries undergoing LNG-IUS insertion. There was no difference among groups in terms of pain at FIGURE 3 Pain related to the LNG-IUS insertion procedure among nulligravid women. ...
... 48, 49 We added the Faces Pain Scale to measure pain to ensure that our results were reliable independent of the scale used. In addition, we evaluated the intracervical block, which may be easier to perform than a paracervical block 29 ; we used a lower dose of lidocaine than previous studies of paracervical blocks 15,16 ; and we inserted only 1 type of IUC. ...
Background:
Fear of pain during the insertion of intrauterine contraceptives is a barrier to using these methods, especially for nulligravidas. An intracervical block may be easier and more reproducible than a paracervical block; however, this intervention has not been evaluated in nulligravid women to reduce pain with intrauterine contraceptive insertion.
Objectives:
To evaluate whether a 3.6mL 2% lidocaine intracervical block reduces pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. Additionally, to assess whether the intracervical block has any effect on the ease of device insertion and on the overall experience with the procedure.
Study design:
In this randomized, double-blind, controlled trial, nulligravidas were block-randomized to one of three arms prior to 52mg levonorgestrel-releasing intrauterine system insertion: 3.6mL 2%-lidocaine intracervical block, sham injection (intracervical dry-needling) or no intervention. The primary outcome was pain at levonorgestrel-releasing intrauterine system insertion. Secondary outcomes were pain at tenaculum placement, ease of insertion (assessed by health care providers) and the overall experience with the procedure (pain with levonorgestrel-releasing intrauterine system insertion compared with expectations, discomfort level, wish to undergo another device insertion in the future, and recommendation of the procedure to others). Participants' pain was measured with a 10-cm visual analog scale and a five-point Faces scale. Pain was summarized into categories (none, mild, moderate, severe) and also analyzed as a continuous variable (mean and 95% confidence interval). Our sample size had 80% power (α=0.05) to detect a 15% difference in pain score measured by visual analogue scale [mean (standard deviation) visual analogue scale score= 5.9 (2.0) cm] and an absolute difference of 20% in the proportion of women reporting severe pain at levonorgestrel-releasing intrauterine system insertion among groups. We used chi-square test and a mixed-effects linear regression model. We calculated the number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion.
Results:
We randomized 302 women (99 to the intracervical block, 101 to the intracervical sham, and 102 to no intervention) and 300 had a successful device insertion. The intracervical block group had fewer women reporting severe pain than the other groups, both at tenaculum placement (intracervical block: 2% vs sham: 30.2% vs no intervention: 15.2%, P<.0001) and at levonorgestrel-releasing intrauterine system insertion (intracervical block: 26.5% vs sham: 59.4% vs no intervention: 50.5%, P<.0001). The mean (95% confidence interval) pain score reported at levonorgestrel-releasing intrauterine system insertion was lower in the intracervical block group than in the other groups [intracervical block: 4.3 (3.8-4.9) vs sham: 6.6 (6.2-7.0), P<.0001; intracervical block: 4.3 (3.8-4.9) vs no intervention: 5.8 (5.3-6.4), P<.0001]. Women from the intracervical block group reported less pain than expected (P<.0001), rated the insertion as less uncomfortable (P<.0001), and were more willing to undergo another device insertion in the future (P<.01) than women in the other groups. The ease of insertion were similar among groups. The number-needed-to-treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion was 2 and 4, respectively.
Conclusion:
A 3.6mL 2% lidocaine intracervical block decreased pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. It also provided a better overall experience during the procedure.
... 12,[16][17][18][19] Patients who received a paracervical block during the procedure also reported decreased pain with tenaculum placement, uterine sounding, and IUD insertion compared with placebo and pain scores were also lower 5 minutes after IUD insertion. 8,12,[20][21] These recommendations are summarized in Table 1. Generally, lidocaine gel has not been showed to be effective for reducing pain with IUD insertion. ...
... For instance, it is important for patients to know that lidocaine paracervical blocks can reduce pain with tenaculum placement and IUD insertion but may cause pain when injected into the cervix. 20 It is also helpful to offer more pain relief options to patients who are at higher risk for experiencing discomfort with IUD insertion, such as patients who are nulliparous, have a history of cervical stenosis, dysmenorrhea, or have significant preprocedure anxiety. 7,9,40 Please refer to Figure 1 for a case study that shows how to use pharmacologic and nonpharmacologic methods to reduce pain and anxiety with IUD insertion. ...
... The risk of bias was assessed for all 39 articles included in this review, as sho [13,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]. ...
... The risk of bias was assessed for all 39 articles included in this review, as shown in [13,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]. These studies have meticulously managed their randomization processes, ensuring a fair allocation of participants to intervention groups. ...
Intrauterine devices (IUDs) are highly effective long-acting contraceptives. However, pain associated with insertion deters some women and impacts satisfaction. This systematic review critically evaluates the effectiveness of local anesthetics, misoprostol, nonsteroidal anti-inflammatory drugs (NSAIDs), and conscious sedation for managing pain associated with IUD insertion. A comprehensive database search including PubMed, Web of Science, Google Scholar, ClinicalTrials.gov, and ProQuest was conducted from inception to July 2023 for randomized controlled trials (RCTs). RCTs assessing interventions for IUD insertion pain were included. Case reports, non-randomized studies, and non-English papers were excluded. Two independent reviewers extracted data on pain outcomes and adverse effects. The risk of bias was assessed using Cochrane tools. Thirty-nine RCTs (n = 12,345 women) met the inclusion criteria. Topical lidocaine effectively reduced pain on consistent findings across multiple high-quality RCTs. Misoprostol pretreatment facilitated easier insertions through cervical ripening. However, evidence for NSAIDs was inconclusive, with some RCTs finding no additional benefits versus placebo. Results also remained unclear for nitrous oxide conscious sedation due to variability in protocols. Nulliparity predicted higher reported pain consistently. Lidocaine and misoprostol show promise for minimizing IUD insertion pain and difficulty. Further optimization is required to standardize conscious sedation and fully evaluate NSAIDs. Improving pain management may increase favorable experiences and uptake of this reliable method.
... Pain reduction therapies for IUD insertion have been widely investigated with mixed results. Studies have reported lidocaine paracervical block [3,4], vaginal or orally administered misoprostol or other length of 8.12 years. These respondents are currently practicing in 15 states, as indicated in Figure 1. ...
... Studies have shown that a buffered 20 cc 1% lidocaine paracervical block is indeed a beneficial pain relief option, but providers have varying attitudes toward efficacy [3]. One provider stated that she feels like the paracervical block is more painful for her patients and adds unnecessary time to the procedure. ...
Context: The intrauterine device (IUD) is one type of long-acting reversible contraceptive that is becoming increasingly popular among patients and healthcare providers alike, though many are deterred from using this option due to pain or fear of pain with IUD insertion. While the IUD insertion process itself is standardized, the use of pain medication is not. There is a lack of research regarding provider preference in analgesic use for IUD insertion procedures, which analgesics are being provided to patients, and under which circumstances. This study aims to explore which analgesics are being used routinely in clinical settings, which patient populations are more likely to receive or benefit from these treatments, and why. Secondarily, this study aims to evaluate the impacts of provider characteristics such as location of training and practice, length of practice, and type of training in analgesic administration.
Methods: Various national organizations were contacted via email and asked to distribute the “IUD Pain Management” survey via discussion board or email newsletter. This survey was developed to gather demographic information on providers of IUD placement procedures and evaluate trends in analgesic methods used based on provider and patient characteristics. Additionally, the survey included an opportunity for participants to agree to participate in a brief interview to further elaborate on their responses via phone. Survey responses were collected and evaluated on the secure QuestionPro platform. Results from the interview were qualitatively assessed by coding recurrent themes between participant interviews.
Results: Survey respondents represented physicians from family medicine and OB-GYN specialties, as well as nurse practitioners, registered nurses, physician assistants, and OB-GYN resident physicians. The average length of clinical practice is 6.7 years. The majority of respondents reported offering some sort of analgesic for IUD insertion procedures, with nonsteroidal anti-inflammatory drugs being the most commonly used. Participants also reported an increased likelihood of prescribing analgesics for adolescent and nulliparous patients. Participant interviews included themes such as patient perception of pain, provider training, barriers to access, and alternative analgesic options.
Conclusions: Our study has identified a significant amount of variation in practices regarding analgesic use for IUD insertion procedures and highlighted some underlying causes of these inconsistencies. Future studies should further investigate trends in analgesic administration in IUD insertion procedures with a larger sample size and delve into factors such as provider education and barriers to access.
... A median 100mm visual analogue scale (VAS) for pain scoring was used in our study which was the same as [6,13,2] . This pain scale used 1to 100 pain scoring system numbered from 1 to 100 with no pain at 1 and worst pain at 100. ...
... The current study is in agreement also with Mody et al. [13] they concluded that 20 cc 1% lidocaine paracervical block decreases pain with IUD placement, uterine sounding, 5 min after placement and overall pain perception. A total 64 women were enrolled and analyzed (33 in paracervical arm, 31in the no-block arm). ...
... 269,273,274 Within 5 minutes after insertion, reported mean pain scores are low. 272,275 In studies reporting both pain scores and a description of the experience, moderate pain scores correlate with descriptions of discomfort rather than pain. 272,275 Evidence level 2- ...
... 272,275 In studies reporting both pain scores and a description of the experience, moderate pain scores correlate with descriptions of discomfort rather than pain. 272,275 Evidence level 2- ...
FSRH Guideline on Intrauterine Contraception
... Lidocaine 2% gel, misoprostol and most NSAIDS were ineffective in reducing pain [7]. Paracervical block using 1% lidocaine, although paracervical injection of 10 ml solution itself is painful, was reported to be useful for pain perception compared to placebo [8,9]. More recently, in a meta-analysis of randomized controlled trials, vaginally administered dinoprostone was also found to be effective for IUD insertion-related pain relief [10]. ...
... More recently, in a meta-analysis of randomized controlled trials, vaginally administered dinoprostone was also found to be effective for IUD insertion-related pain relief [10]. Although there are many studies on pain relief during IUD insertion, surprisingly standardized protocol is lacking [1,[6][7][8][9][10][11]. ...
Purpose
Intrauterine device (IUD) is one the most effective contraceptive methods with reversible long-term effects. However, the major drawback of IUD use is pain perception during the insertion of the device. The aim of this study is to investigate the effects of bilateral LI4 acupuncture, administered before IUD insertion, on pain perception.
Methods
This is a prospective randomized controlled study. It was held in Community Health Center in Niğde, Turkiye. Individuals enrolled in the study were randomized into the acupuncture group and non-intervention group. Acupuncture group received bilateral LI4 acupuncture prior to IUD insertion while others received no interventions. After IUD insertion, 10 cm visual analog scale (VAS) score was evaluated at 3rd minute and at 10th minute. Health care provider performing the IUD insertion and VAS evaluation was blind to randomization.
Results
In total 72 participants were included in the study. The VAS scores were significantly lower in the acupuncture group both at 3rd minute and at 10th minute (1.93 ± 1.68; 3.81 ± 1.95; p < 0.001 and 0.53 ± 0.84; 1.64 ± 1.10; p < 0.001 respectively). Linear regression analysis showed that acupuncture was a significant predictor for lowering VAS both at 3rd minutes and 10th minutes following IUD insertion (p < 0.001).
Conclusion
This is the first randomized controlled clinical study investigating the effects of acupuncture on pain control during IUD insertion. The results demonstrated that bilateral LI4 acupuncture provides significant pain relief at both cervical and fundal components. Acupuncture prior to IUD insertion is a significant predictor of lowering overall VAS scores of individuals.
Trial registration
NCT04963582.
... The block provides analgesia during the cervical pass of the sampling device or manipulation of the cervix. A study showed that paracervical block decreased the pain during intrauterine device placement in 64 nulliparous women [4]. ...
... According to previous trials, we calculated those 123 participants would be required for 80% power with a type I error (α) rate of 5% to detect this difference with 3% drop-out rate [4,5]. Categorical variables were analysed with frequency tables, and descriptive statistics were calculated for continuous variables. ...
Objectives:
We aimed to evaluate the effect of paracervical block (PCB) on endometrial sampling procedures, to assess the effect on pain of waiting between PCB and intervention, and to compare the effectiveness of PCB with oral non-steroidal anti-inflammatory drugs (NSAID) for decreasing the pain levels associated with endometrial biopsy.
Material and methods:
A total of 123 participants were divided into four groups as Group 1: Waiting 1 minute after PCB, Group 2: Waiting 3 minute after PCB, Group 3: Control group, and Group 4: Waiting 60 minute after taking oral NSAIDs. The success of analgesic measures used for endometrial biopsy during and 30 minutes after the procedure was compared with the Numeric Pain Rating Scale (NPRS) system.
Results:
The Numeric Pain Rating Scale (NPRS) 0 score was 2.60 (± 2.42) in Group 1; 1.60 (± 1.73) in Group 2; 5.30 (± 2.10) in Groups 3; 5.63 (± 1.99) in Groups 4. NPRS 30 score was 0.80 (± 0.88) in Group 1; 0.43 (± 0.81) in Group 2; 1.90 (± 1.32) in Groups 3; 2.70 (± 1.41) in Groups 4. The pain was significantly less in the paracervical block groups compared to control and oral NSAIDs groups. However, there was no significant difference in NPRS 0 (p = 0.196) and NPRS 30 (p = 0.191) scores between Group 1 and Group 2. There was no significant difference in NPRS 0 and NPRS 30 scores between control group and oral NSAID group.
Conclusions:
Paracervical block (PCB) is an effective method and superior to oral NSAIDs. Waiting 1 minute or 3 minutes after PCB were equally effective.
... A paracervical block is a single-injection of a longacting local anesthetic around the uterine cervix at the time of surgery [11,12]. A paracervical block can minimize risks associated with opioid analgesics or intravenous or epidural patient-controlled analgesia (PCA), with fewer side effects and a faster recovery [11,13]. However, it is controversial whether paracervical blocks is required as a method for pain reduction in laparoscopic hysterectomies, because of inconsistent results of the current literature [14,15]. ...
... The characteristics of a total of four studies including the present study are summarized in Table 3 (Ref. [13,14,21]). Of the four studies, three of the studies were based in the USA [14,15,22] and one was in South Korea. ...
Background
To determine the effect of a paracervical block in laparoscopic hysterectomy on postoperative pain relief.
Method
A total of 86 patients scheduled for total laparoscopic hysterectomy for benign gynecologic diseases were randomly assigned to the experimental group (n = 43) and the control group (n = 43). Patients were received a paracervical injection that was either 10 mL of 0.5% bupivacaine with 1 : 200,000 epinephrine or 10 mL of normal saline. The primary outcome was the postoperative pain score which was assessed using a visual analog scale at 2, 4, 6, 8, and 12 hours after surgery. The secondary outcome was the postoperative rescue analgesic requirement within 12 hours after surgery.
Results
Baseline characteristics were similar in both groups. Postoperative pain scores did not significantly differ between groups. Rescue analgesia requirements were also statistically similar in both groups.
Conclusion
Adding a paracervical block with preemptive local analgesia in patients undergoing laparoscopic hysterectomy did not reduce postoperative pain and postoperative rescue analgesia requirements.
... A paracervical block with lidocaine is one of the most successful techniques for reducing pain. 4,5,6 Unfortunately, paracervical blocks involve an injection given at up to 4 sites adjacent to the cervix. To avoid injection site pain, vaginal lidocaine gel administered by the patient has also been studied for first-trimester surgical abortion-related pain and was found to be noninferior to a paracervical block in reducing pain in a randomized trial. ...
Patients should receive appropriate pain relief when undergoing procedures. This article canvases historical and sociological underpinnings of how clinicians have responded and should respond in the moment to patients' pain during elective gynecologic procedures, such as intrauterine device placement and first-trimester abortion. This article then considers evidence-based techniques for responding to patients' pain expressions and experiences during such procedures. Finally, this article addresses the nature and scope of clinicians' obligations to respond in the moment to patients' needs when complete pain relief might not be possible.
... Although patient-reported pain for this procedure can vary [3,6], a recent survey reported that 78% of respondents rated their IUD insertion pain as moderate to severe, with 46% experiencing vasovagal symptoms [5]. In attempts to mitigate pain during IUD insertion, several pharmacological interventions have been tested with mixed results [6][7][8][9][10][11][12][13]. For example, certain formulations of lidocaine, such as cervical lidocaine gel and paracervical blocks, have been shown to be effective in reducing pain both during and after the procedure [6-9, 11, 13]. ...
Background
The intrauterine device (IUD) is a highly effective form of long-acting reversible contraception, widely recognized for its convenience and efficacy. Despite its benefits, many patients report moderate to severe pain during and after their IUD insertion procedure. Furthermore, reports suggest significant variability in pain control medications, including no adequate pain medication. The aim of this evaluation was to assess the pharmaceutical pain medication types, proportions, and trends related to IUD insertion procedures within the Veterans Health Administration (VHA).
Methods
IUD insertion procedures documented in the VA electronic health record were assessed from 1/1/2018 to 10/13/2023. Descriptive statistics described patient and facility characteristics while annual trends were assessed using linear regression.
Results
Out of the 28,717 procedures captured, only 11.4% had any form of prescribed pain medication identified. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were the most frequently prescribed pain medication category (8.3%), with ibuprofen being the most common pain medication overall (6.1%). Over the assessment period, there was an average annual increase of 0.52% (p = 0.038) of procedures with prescribed pain medication, increasing from 10.3% in 2018 to 13.3% in 2023.
Conclusions
Although IUD insertion procedures have been seeing an increase in prescribed pain medication, the overall proportion remains disproportionality low relative to the pain experienced. Additionally, when pain interventions were initiated, they disproportionally utilized medication that have been shown to be ineffective. The intent of the work is that the information will help guide data driven pain medication strategies for patients undergoing IUD insertion procedures within the VHA.
... This mild pain intensity is worth communicating to patients before surgery. Similar results were reported by Mody, who used a pericervical block with 20 mL of 1% lignocaine [25]. In our study, there was a tendency toward lower pain values at the anesthesia stage as the subjects' age increased, though this did not reach statistical significance. ...
Hysteroscopy is an endoscopic diagnostic and therapeutic method traditionally performed under general anesthesia but increasingly under local anesthesia. Today, it is considered the gold standard in gynecology. This minimally invasive procedure allows for a detailed assessment of the uterine cavity’s interior and the removal of abnormal changes within it and is applicable to patients of all ages. Background/Objectives: The purpose of the present study was to evaluate pain during hysteroscopy under local anesthesia at different stages of the procedure, identifying which stage is the most painful (GUBBINI Mini Hystero-Resectoscope; Tontarra Medizintechnik, Tuttlingen, Germany). Methods: The study included patients between the ages of 21 and 80 years. They were divided into two groups: the diagnostic hysteroscopy (HD) and the operative hysteroscopy (HO) groups. Pain measurements on the VAS scale were taken at each stage of the hysteroscopic procedure. After each stage, the operator asked the patient to indicate the maximum perceived pain value: after pericervical anesthesia was administered (VAS1), during the installation of equipment (between the removal of the speculum and the insertion of the hysteroscope into the vagina) (VAS2), after insertion of the hysteroscope and visualization of the external orifice of the cervical canal (VAS3), after passage of the hysteroscope through the cervical canal (VAS4), and after completion of the procedure in the uterine cavity (VAS5). The duration of each stage of the procedure was measured with a stopwatch: administration of pericervical anesthesia (T1), time between the removal of the speculum and the insertion of the hysteroscope into the vagina (T2), insertion of the hysteroscope into the vagina until the outer orifice of the cervical canal became visible (T3), passage of the hysteroscope through the cervical canal (T4), and the hysteroscopy procedure itself (T5). Results: The highest pain rating was for the canal passage stage (VAS4: 2.47 ± 2.48 points), followed by the procedure itself (VAS5: 2.12 ± 2.33 points). Anesthesia was also reported as quite painful, while the lowest pain was noted during the assembly stage. Overall pain scores for the entire procedure (VASmax) ranged from 3.5 ± 2.37. Conclusion: In conclusion, we found that the passage through the cervical canal was the most painful moment. Overall, hysteroscopy under pericervical anesthesia was not associated with significant pain. Special attention should be given to postmenopausal patients, as they experience more pain during the passage of the hysteroscope through the cervical canal. This group may benefit from additional pain management strategies during the procedure.
... However, there was no significant reduction in pain with cervical grasping when 1% lidocaine was injected into the cervix (p=0.268) [6]. Another study found that the use of 2% lidocaine injected into the cervix did not lead to any significant reduction in pain during IUD insertion (p=0.4) or post IUD insertion (p=0.1) ...
This study investigates the various methods of pain management during the insertion of intrauterine devices (IUDs) in nulliparous women. Currently, the only recommended method of pain management is 800 mg of ibuprofen taken one hour before insertion of the IUD. However, women continue to experience pain during the procedure. A scoping review was conducted using CINAHL, Medline, Web of Science, and Embase with inclusion criteria being English peer-reviewed articles from the last 10 years, involving nulliparous women of at least 18 years of age. The research reveals that management to minimize pain during IUD insertion can include oral analgesics, cervical blocks, and cervical softening and dilation with prostaglandins. The effect of pain management when using these techniques was further examined throughout the various steps of IUD placement, including cervical grasping, IUD insertion, and post IUD insertion. Ibuprofen is the current recommended analgesic; however, studies show that there was no significant reduction in pain found when ibuprofen is used. Alternatively, 500 mg of naproxen sodium taken prior to IUD insertion showed a significant reduction in post-IUD insertion pain (p=0.01) but did not show any significant reduction in pain during cervical grasping or during IUD insertion into the uterus. Cervical blocks using 1% lidocaine were shown to decrease pain during cervical gripping (p=0.002) and IUD insertion compared to the control group (p=0.005). The results of cervical blocks differed based on whether 1% lidocaine was injected or if a 2% lidocaine gel was used, but no significance was shown. Furthermore, cervical softening and dilation with dinoprostone 3 mg and misoprostol 3 mg demonstrated a reduction in pain during all stages of IUD insertion and after insertion (p<0.01). Pharmacological interventions with oral analgesics, lidocaine, and prostaglandins, such as dinoprostone and misoprostol, have all demonstrated some level of pain control during the IUD insertion procedure, but the use of prostaglandins and 2% lidocaine gel has been demonstrated to have the most clinically significant effect on pain control. Additionally, there has been some research examining the impact of verbal analgesics, which involves the provider using a calm, soothing voice and slow speech to put the patient at ease, and the role that anxiety about IUD insertion can influence pain, but further research is needed to determine its significance. This research provides valuable insight into enhancing the improvement of pain during and after the insertion of IUDs for nulliparous women.
... 5 In attempts to mitigate pain during IUD insertion, several pharmacological interventions have been tested with mixed results. 6,7,8,9,10,11,12,13 For example, certain formulations of lidocaine have been effective, while cervical ripening agents (prostaglandins) and most non-steroidal anti-inflammatory drugs (NSAIDs) were ineffective in managing pain during or after insertion. [9][10][11] During the procedure, the IUD is inserted by clamping the cervix using a tenaculum, followed by measuring the depth of the uterine cavity, placement of the IUD, trimming of the strings, and confirmation of appropriate placement. ...
Background: The intrauterine device (IUD) is a highly effective form of long-acting reversible contraception, widely recognized for its convenience and efficacy. Despite its benefits, many patients report moderate to severe pain during and after their IUD insertion procedure. Furthermore, reports suggest significant variability in pain control medications, including no adequate pain medication. The aim of this evaluation was to assess the pharmaceutical pain medication types, proportions, and trends related to IUD insertion procedures within the Veterans Health Administration (VHA).
Methods: IUD insertion procedures documented in the VA electronic health record were assessed from 1/1/2018 to 10/13/2023. Descriptive statistics described patient and facility characteristics while annual trends were assessed using linear regression.
Results: Out of the 28,717 procedures captured, only 11.4% had any form of prescribed pain medication identified. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were the most frequently prescribed pain medication category (8.3%), with ibuprofen being the most common pain medication overall (6.1%). Over the assessment period, there was an average annual increase of 0.52% (p=0.038) of procedures with prescribed pain medication, increasing from 10.3% in 2018 to 13.3% in 2023.
Conclusions: Although IUD insertion procedures have been seeing an increase in prescribed pain medication, the overall proportion remains disproportionality low relative to the pain experienced. Additionally, when pain interventions were initiated, they disproportionally utilized medication that have been shown to be ineffective. The intent of the work is that the information will help guide data driven pain medication strategies for patients undergoing IUD insertion procedures within the VHA.
... Esta técnica consiste na injeção local de 1% de lidocaína 54 . Contudo, as técnicas de anestesia local por injeção causam considerável desconforto e pode conduzir a complicações graves, tais como lesões vasculares ou toxicidade local 55,56 . No caso específico da lidocaína, é ainda necessário a monitorização da toxidade sistémica e a confirmação da disponibilidade de equipamentos de reanimação 57 . ...
Office gynecological procedures are crucial for women health. New anesthetic methods that replace general anesthesia propelled the transition from the operating room to an office setting of multiple interventions (insertion of intrauterine devices, biopsies and hysteroscopies with or without with or without minor therapeutic procedures). Moderate to severe pain is often experienced by women, leading to the interruption of the procedure. No consensus exists upon routine use of analgesia during these office procedures. More effective pain control strategies and guidelines are needed for pain relief in outpatient gynecological procedures. The reflection in this work is intended to pave the way for a generalized pain management in gynecological procedures to widespread satisfy women expectations and needs.
... This shows that the technique was well-tolerated by more than 90% of patients, even without any pain management. Paracervical or intracervical block, used to reduce the pain associated with IUD insertion 17,18 , may represent alternatives for cases with severe pain during the IUD repositioning procedure. However, no studies have evaluated this approach. ...
Objectives:
To describe the outcomes of an ultrasound-guided intrauterine device (IUD) repositioning technique without sedation for partially expelled IUDs in our outpatient clinic.
Methods:
This descriptive feasibility study included data of partially expelled IUDs from patients of our outpatient clinic from January 2016 to February 2020. We repositioned the partially expelled IUDs (IUDs with the vertical arm extending partially or entirely through the cervical canal) at the uterine fundus using a Hartmann alligator forceps under ultrasound visualization. We extracted data from medical records related to the procedure and the 6-month follow-up. The primary outcome was the success rate of the repositioning procedure, defined by ultrasound confirmation of the entire IUD above the internal os. Secondary outcomes included the retention rate of the repositioned IUD at 6 months, expulsion rate of the repositioned IUD within 6 months, and the description of complications.
Results:
We included data of 55 partially expelled IUD (35 levonorgestrel-IUDs and 20 copper-IUDs) referred to be repositioned. This intervention successfully repositioned 51 IUDs (93%), while the procedure was not completed in 4 patients due to pain. The Obstetrics and Gynecology trainees performed 48 (87.3%) out of 55 procedures. Among the 51 successfully repositioned IUDs, 9 (17.6%) were expelled within six months and 6 patients were lost to follow-up. No uterine perforation or infection-related complications occurred within 6 months of the procedure.
Conclusions:
The ultrasound-guided IUD repositioning technique seems a safe and feasible approach for partially expelled IUDs. This article is protected by copyright. All rights reserved.
... Pain during IUD placement is not confined to insertion, as the use of tenaculum, the uterine sounding, and the anesthetic injection itself can also contribute to an uncomfortable experience [26]. Therefore, the current evidences do not recommend the routinely use of intracervical block, although this procedure has been shown to reduce pain scores in previous studies [21,22,[24][25][26][27][28][29][30][31]. ...
Background
To compare the effectiveness of 550 mg naproxen sodium versus 6 mL 2%-lidocaine intracervical block in pain lowering at the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) placement in young women.
Methods
In this randomized controlled trial, 100 women aged 15–24 years were block-randomized to receive either 6 mL 2%-lidocaine intracervical block 5 min before the LNG-IUS insertion or 550 mg naproxen 30 min before the procedure. Forty-nine women received 550 mg naproxen and 51 received intracervical block. The primary outcome was pain at LNG-IUS insertion. Secondary outcomes were ease of insertion, insertion failures, and correct IUS positioning. Neither participants nor doctors were blinded. Pain at insertion was assessed by using a Visual Analog Scale (VAS).
Results
Women randomized to lidocaine intracervical block presented lower mean pain score at insertion, when compared to women who received naproxen (5.4 vs. 7.3, respectively; p < 0.001). Parous women had a 90.1% lower chance of experiencing severe pain ( p = 0.004). There was a 49.8% reduction in the chance of severe pain for every 1-cm increase in the hysterometry ( p = 0.002). The only complication observed during insertion was vasovagal-like reactions (7%). The insertion was performed without difficulty in 82% of the women. Participants in the intracervical block group presented higher proportion of malpositioned IUS on transvaginal ultrasound examination compared to women in naproxen group. Nevertheless, all the malpositioned IUS were inserted by resident physicians.
Conclusion
Lidocaine intracervical block was found to be more effective than naproxen in reducing LNG-IUS insertion pain.
Trial registration number : RBR-68mmbp, Brazilian Registry of Clinical Trials, Retrospectively registered (August 4, 2020), URL of trial registry record: https://ensaiosclinicos.gov.br/rg/RBR-68mmbp/ .
... As research in IUD insertion pain management continues, studies should consider evaluating whether their analgesic interventions are beneficial for those with dysmenorrhoea. For instance, recent trials have demonstrated promising reductions in IUD insertion pain with a 1% lidocaine paracervical block and a 2% lidocaine intracervical block among nulliparas [24][25][26] ; it would be valuable to examine whether these results are applicable to individuals with dysmenorrhoea (notably excluded from one of the studies), and whether the block itself causes more pain among this population. ...
Background
Understanding predictors of pain with gynaecological procedures may facilitate individualised counselling and pain management. We aimed to study the effect of dysmenorrhoea on intrauterine device (IUD) insertion pain.
Methods
This was a planned secondary analysis of a randomised trial evaluating self-administered lidocaine gel versus placebo for IUD insertion pain. We included those participants who reported menses in the past 3 months. We assessed dysmenorrhoea (in the past 3 months) and procedural pain using a 100 mm visual analogue scale (VAS). We categorised dysmenorrhoea as none/mild (<40 mm), moderate (40–69 mm) or severe (≥70 mm). We assessed participant pain scores at speculum insertion, tenaculum placement, IUD insertion, and overall. We compared median procedural pain scores by dysmenorrhoea group with three-way and post hoc pairwise analyses.
Results
We analysed 188 participants. Demographic characteristics were similar among the three dysmenorrhoea groups. Pairwise comparisons revealed higher median procedural pain scores in the severe dysmenorrhoea group compared with the none/mild dysmenorrhoea group at speculum insertion (25 mm vs 8 mm; p=0.007), tenaculum placement (51 mm vs 31 mm; p=0.04) and IUD insertion (74 mm vs 61 mm; p=0.04). Overall pain did not differ among the three groups (p=0.32).
Conclusions
Patients with severe dysmenorrhoea experienced increased pain with all aspects of IUD insertion, including speculum and tenaculum placement, compared with those with only mild or no dysmenorrhoea. Clinicians may consider this finding when providing individualised counselling and pain management for patients undergoing IUD insertion and other gynaecological procedures. Larger studies are needed to validate the effect of dysmenorrhoea severity on pain throughout IUD insertion.
... 1,2 However, a recent RCT (N = 64) investigated use of a 1% lidocaine paracervical block buffered with sodium bicarbonate. 6 Participants reported 22% more pain with block administration compared with placebo (P = .003), and there was no significant difference in pain between the 2 arms with the placement of the tenaculum (P = .268). ...
... Several effective pharmacologic interventions to reduce pain with IUD insertion exist, including preprocedure oral naproxen, and lidocaine-prilocaine cream. 24 Tramadol has also shown effectiveness in pain reduction, but because of recommendations to use the minimum effective opioid dose to reduce unintended long-term use, we recommend avoiding narcotic receptor agonists in favor of other effective pain management strategies. 25 Nonpharmacologic interventions to increase understanding and reduce anxiety should always be used, including counseling about effectiveness, the insertion and removal process, risks, benefits, costs, effect on fertility, menstrual effects, length of use, and similarities and differences among the various types of IUDs. ...
Study objective:
To identify predictors of anticipated pain with intrauterine device (IUD) insertion in adolescents and young women.
Design:
We performed linear regression to identify demographic, sexual/gynecologic history, and mood covariates associated with anticipated pain using visual analog pain scores (VAS) collected as part of a single-blind randomized trial of women receiving a 13.5 mg levonorgestrel IUD.
Setting:
Three academic family planning clinics in Philadelphia PA.
Participants:
Ninety-three adolescents and young adult women age 14-22.
Intervention:
Participants received either a 1% lidocaine or sham paracervical block.
Main outcome measures:
Anticipated pain measured using a Visual Analog Scores (VAS) before and perceived pain at 6 time points during the IUD insertion procedure.
Results:
Black or African-American participants had a median anticipated pain score of 68 (IQR 52, 83), White participants had a median anticipated pain of 51 (IQR 35, 68), while participants of other races had a median anticipated pain score of 64 (IQR 36, 73); p=0.012. In multivariate analysis, race was the only covariate that significantly predicted anticipated pain at IUD insertion. Women with anticipated pain scores above the median had significantly higher perceived pain during all timepoints of the IUD insertion procedure.
Conclusions:
Increased anticipated pain is associated with increased perceived pain with IUD insertion. Black adolescent women experience greater anticipated pain with IUD insertion. This population may benefit from counseling and clinical measures to reduce this barrier to IUD use.
Purpose of review
Intrauterine devices (IUDs) are safe and effective for most adolescents and young adults (AYA) for both contraception and menstrual management. However, multiple barriers exist to placement, including procedure-associated pain. There has been a recent call to action for healthcare providers to optimize pain management strategies for IUD insertion.
Recent findings
Approach to pain management for IUD insertion varies significantly among providers, and there is no standardized approach to comfort optimization. Several methods of pain control for IUD insertion, both pharmacologic and nonpharmacologic, have been studied, though many have variable results.
Summary
Approaching IUD insertion counseling through a lens of patient autonomy and reproductive justice will likely improve the patient experience and help providers to work toward enhancing comfort during the procedure. Further research is needed to determine optimal pain control strategies for IUD insertion.
Nearly half of all pregnancies worldwide are unintended. Intrauterine devices are an effective, long-acting form of pregnancy prevention that require minimal maintenance, and also can be used in patients with menorrhagia. However, they are underused because of pain associated with their insertion. Topical and local anesthesia are good options for reducing procedural pain in select patients. IUD placement falls within the scope of practice for physician associates/assistants (PAs) practicing in family medicine, internal medicine, and women's health. PAs should be aware of these additional analgesia options available to patients in order to increase use of effective contraception.
Objective
To assess placement outcomes using a levonorgestrel 52 mg intrauterine device (IUD) inserter designed for single‐handed use.
Methods
Investigators enroled participants 18–45 years to have the IUD inserted using a redesigned inserter with removal 5–15 min after placement. Physicians and participants provided feedback on their insertion experience.
Results
Successful placement occurred in 48 of 50 (96.0%) enroled participants. Investigators rated insertion device loading “easy” in 49 (98.0%) and placement “easy” in 44 (88.0%) cases. Cramping pain was reported at insertion by 47 (94.0%) participants, mostly mild (32 [64.0%]) or moderate (11 [22.0%]).
Conclusion
The single‐handed inserter is easy to use and results in high rates of insertion success.
In recent years, we have witnessed significant advances in obstetric anesthesia, providing greater safety for the mother and the fetus, as well as an improvement in pain management procedures during labor.
This volume presents updates in obstetrics and gynecology that are reflective of the changes in the demographics and associated clinical presentations of gynecological pathologies. It compiles state of the art information on the subject in 20 chapters contributed by more than 50 experts in obstetric anesthesia. The main objective of this volume is to inform and update readers about the different aspects essential to the practice of anesthesia and analgesia during pregnancy, labor, cesarean section and puerperium. The contents also include information about the management of pregnant women with different pathologies and high-risk pregnancies.
The authors believe that it is essential for all anesthesiologists to be aware of the latest advances and well-contrasted scientific evidence that will allow them to carry out their usual clinical activity.
The volume approaches the subject in a clear and didactic way for the benefit of all professionals involved in this field, including anesthesiologists, gynecologists, obstetricians, surgeons, clinicians and allied healthcare service providers.
Long-acting reversible contraceptive (LARC) methods are effective options for pregnancy prevention. Currently available products in the United States include an etonogestrel implant, a copper intrauterine device (IUD), and several levonorgestrel IUDs. With increasing prevalence and duration of use, our understanding of efficacy, risks, and benefits has evolved. In addition to a brief discussion on nomenclature and LARC use within a framework of bodily autonomy and reproductive justice, this review covers clinical challenges with placement and removal, evidence-based duration of use, and how to mitigate side effects. Although all obstetrician-gynecologists as well as primary care clinicians can safely provide LARCs, complex family planning specialists are an expert referral source for challenging cases and evidence-based care as contraceptive technology continues to develop.
Before the established popularity of epidural anesthesia for labor and delivery, paracervical block was one of the most frequently used regional techniques administered for analgesia during the first stage of labor. Paracervical block has a limited role in modern obstetric practice, except in cases where central neural blockade is not feasible or is unavailable. Frankenhauser’s ganglion, which contents all the visceral sensory nerve fibers from the uterus, cervix, and upper vagina, is located in the lateral fornix of the upper vaginal canal. It is that ganglion or plexus of nerves that is blocked by a paracervical block.KeywordsParacervical (uterosacral block)IndicationsInjection techniqueComplications
Objective
To assess the awareness, knowledge, and misconceptions of young people regarding long-acting reversible contraceptives (LARCs).
Design
We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines of MEDLINE-Ovid, Embase, and Cumulative Index to Nursing and Allied Health Literature. A random-effects meta-analysis was performed with formal tests for heterogeneity and publication bias. Additional outcomes were summarized using thematic analysis.
Setting
Not applicable.
Patient(s)
Adolescents and young adults (aged 12–25 years) with a uterus.
Intervention(s)
Not applicable.
Main Outcome Measure(s)
Patient-reported outcomes related to awareness, knowledge, and misconceptions of LARCs (including intrauterine devices, subdermal implants, and injections) were analyzed.
Result(s)
Of the 4,077 database citations, we included 40 studies encompassing 10,470 adolescents and young people. Twenty studies were eligible for meta-analysis. The pooled prevalence described that only 65.0% (95% confidence interval [CI], 51–78) of participants were aware of at least 1 type of LARC (I² = 100). The meta-regression noted that the region, risk of bias, gravidity, sexual history, previous LARC experience, and postsecondary education were not associated with awareness. There were numerous misconceptions regarding eligibility, safety, and usage. Notably, 62% (95% CI, 20–91) did not understand that LARCs could be used in nulliparous individuals, and 37% (95% CI, 21–56) believed that LARCs could cause infertility.
Conclusion(s)
There are notable knowledge gaps among adolescents and young people regarding LARCs, such as eligibility criteria, the reversibility of long-acting options, and misconceptions regarding infertility. Clinicians should specifically counsel regarding the suitability for LARCs in nulliparous populations and that LARCs do not cause infertility.
STUDY OBJECTIVE
Evaluate the impact of nitrous oxide on patient reported pain for placement of intrauterine systems (IUSs) in adolescents.
STUDY DESIGN
Prospective observational study.
SETTING
Intrauterine system placement in an ambulatory clinic compared to placement with nitrous oxide in a hospital-based sedation unit.
PARTICIPANTS
English-speaking adolescents aged 12 to 20 presenting to a pediatric and adolescent gynecologist with a medical indication for IUS placement.
MAIN OUTCOME MEASURES
Patient reported procedural pain measured on a visual analog score (VAS) two minutes post IUS insertion procedure. Secondary outcome measurement of likelihood of recommending an IUS to a peer.
RESULTS
Seventy-four patients agreed to participate. Forty-five patients underwent intrauterine system placement in clinic. Controlling for age, history of dysmenorrhea, and body mass index, a significant time (change in reported pain scores pre- vs. post IUS insertion) by treatment (nitrous oxide versus standard-of-care) interaction was observed for patient reported pain (b = -29.32mm, p < .01). Patients receiving nitrous oxide were more likely to recommend an intrauterine placement than patients who received the current standard-of-care for pain management (b = 0.47, p = .02) after controlling for age, baseline pain score, and dysmenorrhea history.
CONCLUSION
Patient-reported pain was attenuated for patients who received nitrous oxide relative to those who received standard IUS placement. Patient reported satisfaction was higher for patients who received nitrous oxide relative to those who received standard IUS placement.
Resumen
El papel que los anticonceptivos reversibles de larga duración, como los dispositivos intrauterinos (DIU), pueden tener en la reducción de la tasa de embarazos no deseados, hace que superar las barreras a su uso adquiera especial relevancia. En el presente trabajo se revisan algunas de las barreras más comunes al uso de DIU –incluyendo los liberadores de levonorgestrel (DIU-LNG)–, ofreciendo información de utilidad y sugerencias en aspectos clave antes, durante y después de la inserción de estos dispositivos; para ello, se ha revisado la evidencia científica más actual y se aporta la experiencia de los autores allá donde no exista suficiente evidencia. Entre los aspectos considerados antes de la inserción, se revisa la manera de valorar la elegibilidad de la mujer, cómo informarla adecuadamente, la necesidad de saber cuál es el DIU que mejor se adapta a sus características y necesidades y cuál es el mejor momento para insertarlo. Se revisan los estudios acerca de medidas farmacológicas y no farmacológicas que han demostrado tener un efecto en la reducción del dolor durante la inserción de un DIU. Se cometan también factores predictores del dolor y cómo mejorar la vivencia de la mujer durante la inserción puede ayudar a mitigarlo. La posibilidad de complicaciones como una perforación, aunque baja, requiere conocimiento sobre su manejo e informar adecuadamente a la usuaria sobre signos y síntomas indicativos. La inserción de DIU puede ser especialmente dificultosa en mujeres con estenosis post-conización o que hayan sufrido una cesárea, motivo por el que se revisa. Por último, se comenta la actuación en caso de síndrome vasovagal y aspectos post-inserción, como el dolor o la desaparición de hilos, y cuándo es aconsejable realizar visitas de seguimiento.
Objective:
The aim of this study was to estimate the efficacy of preemptive paracervical block or uterosacral ligament infiltration in reducing postoperative pain and opioid consumption after benign minimally invasive hysterectomy.
Data sources:
We searched MEDLINE, Cochrane Library, Embase, ClinicalTrials.gov, and Google Scholar from inception until February 2020.
Methods of study selection:
We identified randomized placebo-controlled trials assessing the primary outcome of pain and opioid consumption after paracervical block or uterosacral infiltration in benign laparoscopic, vaginal, or robotic hysterectomy. Two investigators evaluated studies for risk of bias and quality of evidence.
Tabulation, integration, and results:
We reviewed 219 abstracts; 6 studies met the inclusion criteria: 3 using paracervical block (2 vaginal and 1 laparoscopic) and 3 using uterosacral ligament infiltration (all vaginal). Two studies were included in the meta-analysis (both vaginal hysterectomy). Because of lack of numerical data, or comparison, the other 4 studies are reported in narrative form. Three controlled trials reported a moderate benefit from paracervical block up to 8 hours after vaginal and 4 hours after laparoscopic surgery. Meta-analysis could not be performed because of the lack of numerical data for pooling results or the lack of a laparoscopic hysterectomy comparison group. Three trials reported that uterosacral infiltration decreases pain up to 6 hours after vaginal hysterectomy, and meta-analysis pooling the results of 2 of these studies demonstrated improvement in pain up to 4 hours on a 0- to 100-mm visual analog scale for pain (-19.97 mm; 95% confidence interval, -29.02 to -10.91; P < 0.000). Five trials reported a moderate reduction in cumulative opioid use within 24 hours after vaginal surgery for both paracervical block and uterosacral infiltration. Meta-analysis was not performed for paracervical block because only 1 trial provided suitable data for pooling. Meta-analysis pooling the results of 2 trials of uterosacral infiltration demonstrated opioid consumption of 20.73 morphine milligram equivalents less compared with controls (95% confidence interval, -23.54 to -17.91; P < 0.000).
Conclusions:
There were a total of 6 randomized placebo-controlled studies evaluated in this study. Although a meta-analysis was unable to be performed for all studies because of lack of comparison groups or numerical data, there is evidence that preemptive uterosacral ligament infiltration may reduce postoperative pain and opioid consumption after vaginal hysterectomy. Our study does not allow us to make any substantive conclusions on the use of paracervical block in vaginal hysterectomy or the use of either type of injection in laparoscopic or robotic hysterectomy.
Purpose
This study aimed to assess the pain scores at the insertion of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) among nulligravidas, parous women with previous vaginal delivery and parous women with elective caesarean-delivery without any previous labour or cervix dilation.
Materials and methods
The present research is a prospective, single-cohort study that included 413 women aged 15–49 years who opted for LNG-IUS placement for contraception or treatment of heavy menstrual bleeding. Women who participated in the present study were not submitted to any pharmacological pain-relieving intervention to perform the procedure. Pain at insertion was evaluated by using a Visual Analogue Scale (VAS). Pain was classified as absent (0), mild (1–3), moderate (4–6), or severe (7–10). The women were divided as: (1) nulligravidas, (2) parous women with a previous vaginal delivery, or (3) parous women with elective caesarean-delivery without any previous labour or cervix dilation.
Results
Nulligravidas women presented a higher mean pain score, when compared to women with elective caesarean-delivery and women with previous vaginal delivery (6.6 ± 2.0 vs 5.5 ± 2.1 and 3.9 ± 2.4, respectively; p < 0.001). Nulligravidas and women with elective caesarean-delivery were more likely to have pain classified as moderate or severe (in relation to absent or mild) than women with previous vaginal delivery (p < 0.001). Multiple Linear Regression Analysis demonstrated that 29.5% of all variability of the pain score was explained by two predictor/independent variables: nulligravidas or women with elective caesarean and difficulty at IUD insertion.
Conclusions
Women with previous vaginal delivery had lower pain scores at LNG-IUS insertion when compared to nulligravidas and women with elective caesarean-delivery without any previous labour.
Adolescents face unique challenges in navigating sexual relationships and contraception. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics recommend long acting reversible contraceptives (LARC) as first line for pregnancy prevention in adolescents. LARCs include hormonal and non-hormonal intrauterine devices as well as the subdermal hormonal implant. When given high-quality, comprehensive counseling regarding contraceptive options, including LARCs, studies have shown that a majority of adolescents will choose LARC as their method of choice for contraception. LARCs include levonorgestrel subdermal implant, hormonal intrauterine device and copper intrauterine device. This chapter reviews the types, mechanism of action, risks and benefits and uses of long-acting reversible contraception in the adolescent population.
Objective
To identify sociodemographic and clinical variables associated with severe pain with levonorgestrel 52mg intrauterine system (IUS) placement among nulligravid women.
Study design
We performed a secondary analysis of a randomized trial that evaluated intracervical anesthesia before IUS insertion. We assessed factors associated with severe pain (visual analog scale pain score ≥ 7) immediately after insertion using bivariate and multiple regression analyses.
Results
Overall, 137/300 (45.7%) subjects reported severe pain. In multiple regression analysis, only intracervical anesthesia [RR 0.55, 95% CI 0.37-0.80] and a history of dysmenorrhea [RR 1.36, 95%CI 1.08-1.72)] were associated with severe pain.
Conclusions
Among nulligravid women, a history of dysmenorrhea increases, and intracervical block decreases severe pain during levonorgestrel IUS insertion.
Implications
Dysmenorrhea increases the risk of severe pain at levonorgestrel intrauterine system insertion, while receiving an intracervical lidocaine block decreases this risk. This information can be useful for counseling women prior to device placement and for selecting candidates who may particularly benefit from interventions to reduce pain.
Background
Various medications have been investigated for their efficacy in pain reduction during intrauterine device (IUD) insertion, but there is currently no standard recommendation. This study aimed to investigate the efficacy of 10% lidocaine spray in reducing pain during copper-containing intrauterine device (Cu-IUD) insertion.
Methods
This study was a randomised, double-blind, placebo-controlled trial. Reproductive-age women were randomised at a 1:1 ratio into 10% lidocaine spray or placebo spray group. A 10 cm visual analogue scale (VAS) was used to evaluate pain during several steps of the IUD insertion procedure, and after the procedure.
Results
One hundred and twenty-four women were included and 62 women were randomised in each group. Baseline characteristics between groups were similar. The 10% lidocaine spray group demonstrated significantly lower median VAS immediately after IUD insertion than the placebo group (2.95 (IQR=1.00–5.63) vs 5.00 (IQR=3.35–7.00), respectively; p=0.002). Similarly, women receiving 10% lidocaine spray reported significantly lower median VAS than those receiving placebo during tenaculum use and uterine sounding. The maximum median VAS occurred immediately after Cu-IUD insertion. The proportion of women who reported VAS≥4 during uterine sounding and after IUD placement was significantly lower in the 10% lidocaine group than in the placebo group (p<0.05). Median change in VAS from baseline to IUD placement was significantly different between 10% lidocaine spray group and placebo group (1.85 (IQR=0.08–4.03) vs 3.6 (IQR=2.40–5.80), respectively; p=0.004).
Conclusion
10% lidocaine spray was found to be an effective local anaesthetic method for reducing pain during insertion of Cu-IUD.
Trial registration number
Clinicaltrials.gov NCT03870711
The birth of a child may be one of the most significant events in a women’s life, and it is associated with significant emotional, physical, and painful events during the labor and delivery process. It is critical to give the patient control in decision-making for the labor and delivery process including methods of pain relief. Studies reveal the extent to which a parturient pain is controlled during and after delivery has implications for short- and long-term psychological consequences including but not limited to depression, post-traumatic stress disorder, and negative thoughts about sexual relationships.
Study Objective
To assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52 mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women.
Design
Randomized controlled trial.
Setting
Tertiary referral hospital.
Participants
Nulliparous adolescents and young women aged 18-22 years.
Interventions
Participants were randomly assigned into two groups; dinoprostone group (n=65) received dinoprostone 3 mg vaginally, and placebo group (n=65) received placebo tablets vaginally.
Main Outcome Measure(s)
Primary outcome was pain scores during LNG-IUD insertion measured by visual analog scale (VAS). Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, women satisfaction score, need for additional analgesics, and side effects.
Results
Dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement(2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus(3.55 ± 1.71 vs 5.12 ± 1.37) compared to placebo group(P <0.001). No significant differences were found between both groups regarding anticipated pain scores(P= 0.85), pain during speculum insertion and 20 minutes post-insertion and insertion duration(P=0.53). Women satisfaction, provider reported ease of insertion and need for additional analgesia were significantly better among dinoprostone users(p <0.001, <0.001 and 0.02 respectively). Side effects and procedure complications were similar between the two groups.
Conclusions
Self-administered dinoprostone 3mg vaginally 12 hours prior to a 52 mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.
Objective:
To evaluate the effects of buffered lidocaine on pain scores during vulvar biopsy.
Methods:
We conducted a double-blind, randomized controlled trial, using prefilled, sequentially numbered, randomized syringes to infiltrate either 3 mL of buffered or nonbuffered lidocaine before vulvar biopsy. The primary outcome was a pain score marked on a 100-mm visual analog scale during infiltration. Secondary outcomes included pain scores after the procedure and change from baseline to infiltration. Participants were recruited to detect a clinically meaningful 15-mm difference in pain scores between groups. Sample size was calculated based on the null hypothesis that the mean pain score would be the same in women treated with buffered lidocaine as in those treated with nonbuffered placebo based on prior studies. Categorical data were compared by Fisher exact test, and continuous data were compared between groups by t-test or Wilcoxon rank sum test.
Results:
From July 2015 to April 2018, 129 participants were randomized to one of two groups: nonbuffered lidocaine or buffered lidocaine. One hundred twenty-five were analyzed (nonbuffered n=62, buffered n=63). Four patients were excluded. The majority of participants were non-Hispanic white women with a mean age of 59 years. There was no difference in the primary outcome of pain during infiltration with a mean pain score of 35.8 mm in the buffered lidocaine group compared with 42.2 in the nonbuffered lidocaine group (mean difference -6.4; 95% CI -18.4 to 5.6; P=.3 by Wilcoxon rank sum test). There was also no difference in secondary outcomes of pain over the entire procedure (mean difference -0.3, 95% CI -9.7 to 9.2; P=.7) or change in pain from baseline to infiltration (mean difference -6.9, 95% CI -18.4 to 4.7; P=.2).
Conclusion:
There was no difference in pain scores during vulvar biopsy infiltration between the buffered and nonbuffered lidocaine groups.
Clinical trial registration:
ClinicalTrials.gov, NCT02698527.
Purpose of review:
As politics continue to shape contraception and abortion care, providers have a responsibility to address the specific needs of the adolescent patient. Here we review the current literature on contraception and abortion in adolescents.
Recent findings:
Shared decision-making among patients, parents, and providers is the cornerstone of successful adolescent family planning. Providers should be aware of local state regulations related to consent in minors. When provided directive and noncoercive contraception counseling at no cost, adolescents are motivated and effective decision-makers in their care. Long-acting reversible contraceptives should be offered as the first-line method of contraception in adolescents.
Summary:
Family planning in adolescents presents unique challenges to obstetrician-gynecologists. Improved access to contraception and abortion services is significantly lowering unintended pregnancies rates in adolescents, but more data assessing the effectiveness of interventions in marginalized communities are needed.
First trimester abortions especially cervical dilation and suction aspiration are associated with pain, despite various methods of pain control.
Compare different methods of pain control during first trimester surgical abortion.
We searched multiple electronic databases with the appropriate key words, as well as reference lists of articles, and contacted professionals to seek other trials.
Randomized controlled trials comparing methods of pain control in first trimester surgical abortion at less than 14 weeks gestational age using electric or manual suction aspiration. Outcomes included intra- and postoperative pain, side effects, recovery measures and satisfaction.
Two reviewers independently extracted data. Meta-analysis results are expressed as weighted mean difference (WMD) or Peto Odds ratio with 95% confidence interval (CI).
We included forty studies with 5131 participants. Due to heterogeneity we divided studies into 7 groups:Local anesthesia: Data was insufficient to show a clear benefit of a paracervical block (PCB) compared to no PCB or a PCB with bacteriostatic saline. Pain scores during dilation and aspiration were improved with deep injection (WMD -1.64 95% CI -3.21 to -0.08; WMD 1.00 95% CI 1.09 to 0.91), and with adding a 4% intrauterine lidocaine infusion (WMD -2.0 95% CI -3.29 to -0.71, WMD -2.8 95% CI -3.95 to -1.65 with dilation and aspiration respectively).PCB with premedication: Ibuprofen and naproxen resulted in small reduction of intra- and post-operative pain.Analgesia: Diclofenac-sodium did not reduce pain.Conscious sedation: The addition of conscious intravenous sedation using diazepam and fentanyl to PCB decreased procedural pain.General anesthesia (GA): Conscious sedation increased intraoperative but decreased postoperative pain compared to GA (Peto OR 14.77 95% CI 4.91 to 44.38, and Peto OR 7.47 95% CI 2.2 to 25.36 for dilation and aspiration respectively, and WMD 1.00 95% CI 1.77 to 0.23 postoperatively). Inhalation anesthetics are associated with increased blood loss (p<0.001).GA with premedication: The COX 2 inhibitor etoricoxib, the non-selective COX inhibitors lornoxicam, diclofenac and ketorolac IM, and the opioid nalbuphine were improved postoperative pain.Non-pharmacological intervention: Listening to music decreased procedural pain.No major complication was observed.
Conscious sedation, GA and some non-pharmacological interventions decreased procedural and postoperative pain, while being safe and satisfactory to patients. Data on the widely used PCB is inadequate to support its use, and it needs to be further studied to determine any benefit.
The copper intrauterine device (IUD) is a highly effective and safe contraceptive method, also in nulliparous women. However, insertion of an IUD through a narrow cervix may be technically difficult. Misoprostol has been shown to be effective for cervical priming in non-pregnant women prior to hysteroscopy.
Eighty nulliparous women requesting an IUD were randomly allocated to receive sublingually 400 microg misoprostol and 100 mg diclofenac (misoprostol group) or 100 mg diclofenac alone (control group) 1 h prior to IUD insertion. Cervical dilatation was measured prior to insertion using Hegar pins. Ease of insertion was judged by the investigator. Pain, bleeding and side effects were recorded at insertion and until follow-up performed one month later.
Following treatment with misoprostol, insertion was significantly easier than in the control group [P = 0.039, difference 19.36%, confidence interval (CI) -0.013, 39.99]. Pain estimated on a visual analogue scale (1-10) showed no evidence of a difference between the groups. The overall distribution of side effects did not differ. However, shivering was more common in the misoprostol group (P = 0.0084, difference 23.27%, CI 6.64, 39.90).
Misoprostol facilitates insertion of an IUD, and reduces the number of difficult and failed attempts of insertions in women with a narrow cervical canal. The optimal regimen of misoprostol remains to be defined.
Objective:
To estimate the effect of a 1% lidocaine paracervical nerve block on pain during intrauterine device (IUD) insertion compared with a sham block in adolescents and young women.
Methods:
We conducted a multisite, single-blind, sham-controlled randomized trial in adolescents and young women having a 13.5-mg levonorgestrel IUD inserted. Enrollment occurred at three family planning clinics in Philadelphia, Pennsylvania. Eligible adolescents and young women were aged 14-22 years, nulliparous, not currently or recently pregnant, and English-speaking. Participants were randomized using computer-generated allocation in block sizes of four to receive a 10-mL 1% lidocaine paracervical block or a sham block (1 cm depression of the vaginal epithelium at paracervical block sites with a wooden cotton-tipped applicator). Only patients were blinded. The primary outcome was pain after IUD insertion measured with a 100-mm visual analog scale. Using a two-sided t test and assuming a 20-mm difference in visual analog scale scores, a SD of 28 mm, an α of 0.05, and 90% power, a sample of 43 participants per group was estimated.
Results:
Between March 2015 and July 2016, 95 participants enrolled (47 lidocaine block group; 48 sham block group). All were included in the analysis. Forty-four percent were white, 36% black, 65% privately insured, and 79% previously used contraception. The median visual analog scale score after IUD insertion was 30.0 (95% CI 20.0-58.0) in the lidocaine block group and 71.5 (95% CI 66.0-82.0) in the sham block (P<.001).
Conclusion:
A 10-mL 1% lidocaine paracervical nerve block reduces pain during IUD insertion in adolescents and young women compared with a sham block with pressure on the vaginal epithelium.
Clinical trial registration:
ClinicalTrials.gov, NCT02352714.
Objective:
To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion.
Methods:
In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of Laminaria. Women assessed their pain on a 100-mm visual analog scale. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an α of 0.05 and 80% power, we aimed to enroll 20 patients in each arm.
Results:
From May 2015 to December 2015, 20 women received a paracervical block and 21 received a sham block. Groups were similar in demographics, including parity, history of surgical abortion, and number of Laminaria placed. The paracervical block reduced pain after Laminaria insertion (median scores 13 mm [interquartile range 2-39] compared with 54 mm [interquartile range 27-61], P=.01, 95% CI -47.0 to -4.0). Women who received a paracervical block also reported higher satisfaction with overall pain control throughout the entire Laminaria insertion procedure (median scores 95 mm [interquartile range 78-100] compared with 70 mm [interquartile range 44-90], P=.05, 95% CI 0.0-37.0).
Conclusion:
Paracervical block is effective at reducing the pain of Laminaria insertion. Additionally, a paracervical block increases overall patient satisfaction with pain control during Laminaria placement.
Clinical trial registration:
ClinicalTrials.gov, NCT02454296.
Objective:
To evaluate whether 550 mg oral naproxen sodium given 1 hour before intrauterine device (IUD) insertion is effective for pain relief as compared with placebo.
Methods:
This was a randomized, double-blind, placebo-controlled trial. The primary outcome was pain with IUD insertion measured on a 100-mm visual analog scale (VAS). Our sample size was calculated to detect a 15-mm difference in VAS scores with 80% power (α=0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes postinsertion.
Results:
A total of 118 women were enrolled and analyzed (58 in the naproxen sodium arm, 60 in the placebo arm, 97% nulliparous) between May 11, 2015, and March 25, 2016. There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in median VAS pain scores for the primary outcome of pain with IUD insertion between the naproxen sodium arm compared with the placebo arm (69 compared with 66 mm, P=.89). There were no differences in the secondary outcomes of median VAS pain scores with tenaculum placement (37 compared with 32 mm, P=.97) or uterine sounding (60 compared with 58 mm, P=.66). However, median pain scores postprocedure were lower in the naproxen arm as compared with the placebo arm: 17 compared with 26 mm (P=.01) at 5 minutes and 13 compared with 24 mm (P=.01) at 15 minutes postinsertion.
Conclusion:
Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication.
Clinical trial registration:
ClinicalTrials.gov, http://clinicaltrials.gov, NCT02388191.
Objective:
To examine current levels, current correlates of, and changes in long-acting reversible contraceptive (LARC) use, including intrauterine devices and implants, among females aged 15-44 years using contraception between 2008-2010 and 2011-2013 with specific attention to associations between race, income, and age and their LARC use.
Methods:
We analyzed data from two rounds of the National Survey of Family Growth, nationally representative samples of females aged 15-44 years, consisting of 6,428 females in 2008-2010 and 5,601 females in 2011-2013. We conducted simple and multivariable logistic regression analyses with adjustments for the sampling design to identify demographic characteristics predictive of LARC use and changes in these patterns between the two time periods. In this cross-sectional, descriptive study, our primary outcome of interest was current prevalence of LARC use among all contraceptive users at the time of the interview.
Results:
The prevalence of LARC use among contracepting U.S. females increased from 8.5% in 2009 to 11.6% in 2012 (P<.01). The most significant increases occurred among Hispanic females (from 8.5% to 15.1%), those with private insurance (7.1-11.1%), those with fewer than two sexual partners in the previous year (9.2-12.4%), and those who were nulliparous (2.1-5.9%) (all P<.01). In multivariable analyses adjusting for key demographic characteristics, the strongest associations with LARC use in 2012 were parity (adjusted odds ratios [ORs] 4.3-5.5) and having a history of stopping non-LARC hormonal use (adjusted OR 1.9). Women aged 35-44 years (adjusted OR 0.3) were less likely to be LARC users than their counterparts (all P<.001). Poverty status was not associated with LARC use. There were no differences in discontinuation of LARC methods resulting from dissatisfaction between minority women and non-Hispanic white women.
Conclusion:
During the most recent time period surveyed, use of LARC methods, particularly intrauterine devices, increased almost uniformly across the population of users.
Level of evidence:
III.
To evaluate intramuscular ketorolac compared with placebo saline injection for pain control with intrauterine device (IUD) placement.
We conducted a randomized, double-blind, placebo-controlled trial between July 2012 and March 2014. Patients received 30 mg ketorolac or placebo saline intramuscular injection 30 minutes before IUD placement. The primary outcome was pain with IUD placement on a 10-cm visual analog scale. Sample size was calculated to provide 80% power to show a 2.0-cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement.
A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, body mass index, and race. There were no differences in median pain scores for IUD placement in the placebo compared with ketorolac groups (5.2 compared with 3.6 cm, P=.99). There was a decrease in median pain scores at 5 minutes (2.2 compared with 0.3 cm, P≤.001) and 15 minutes (1.6 compared with 0.1 cm, P≤.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, eight per arm) had a decrease in pain scores with IUD placement (8.1 compared with 5.4 cm, P=.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement.
Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement.
ClinicalTrials.gov; www.clinicaltrials.gov, NCT01664559.
I.
To evaluate if ibuprofen 800mg reduces pain with intrauterine device (IUD) insertion among U.S. women.
We conducted a randomized, double-blind, placebo-controlled trial of women undergoing IUD insertion approximately 2-6weeks following first-trimester uterine aspiration. Subjects were randomized to receive ibuprofen 800mg or placebo 30-45min prior to IUD insertion. A 100-mm visual analog scale (VAS) was administered to measure pain after speculum insertion (baseline) and immediately following IUD insertion.
A total of 202 women were enrolled, with 101 randomized to each group (ibuprofen or placebo). Sociodemographic characteristics and baseline VAS scores were similar between groups. The median pain score with IUD insertion was 41.5mm in the placebo group and 38.0mm in the ibuprofen group (p=.50). Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently. Overall, median pain scores were 17.5mm higher in nulliparous women than parous women (p=.004). Median pain scores did not differ by age, IUD-type, history of dysmenorrhea or time since aspiration.
Administration of ibuprofen 800mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women. Overall, nulliparous women report more pain with IUD insertion than multiparous women.
Copyright © 2014 Elsevier Inc. All rights reserved.
Background:
Potential pain with IUD insertion is a concern for women. Studies have found that systemic and local cervical therapies do not reduce pain scores. Since intrauterine infusion of lidocaine may reduce pain with endometrial aspiration, in this pilot study, we tested whether such infusion through an inexpensive endometrial aspirator could reduce IUD insertion pain scores with IUD insertion.
Study design:
In this randomized, double-blinded, placebo control pilot study of 40 women undergoing IUD insertion, pain scores of women receiving 1.2 mL 2% lidocaine versus normal saline (1:1) infused 3 min prior to IUD insertion were measured using a 0-9-point scale.
Results:
Pain at tenaculum placement was similar between groups. There was no difference in mean pain scores during IUD insertion of women infused with lidocaine (2.95) versus normal saline (3.75), p=.37. Considerable variation in pain scores was noted; 46% of subjects had pain scores ≤2 while 33% had pain scores ≥5.
Conclusion:
Use of 2% lidocaine administered through an endometrial aspirator did not significantly reduce IUD insertion pain scores in this pilot study.
Background:
This study was conducted to investigate the effects of a 1% lidocaine paracervical block on perceived patient pain during intrauterine device (IUD) insertion.
Study design:
We randomized 50 women undergoing IUD insertion to receive either a 10-mL 1% lidocaine paracervical block or no local anesthetic before IUD insertion. Women marked their pain on a 100-mm visual analogue scale (VAS) (0 mm = no pain, 100 mm = worst pain possible) at various points of the procedure (speculum insertion, tenaculum placement, paracervical block administration, IUD insertion and 5 min postprocedure).
Results:
Twenty-six women received the paracervical block before IUD insertion, and 24 received no local anesthesia. Groups were similar in age, parity, ethnicity, education and complications. Women who received the paracervical block reported a median VAS score of 24.0 mm with IUD insertion, and women who did not receive local anesthetic reported a median VAS score of 62.0 mm with IUD insertion; p=.09.
Conclusion:
Compared with no anesthetic, a 1% lidocaine paracervical block did not result in a statistically significant decrease in perceived pain with IUD insertion.
Despite lack of efficacy data, the majority of first-trimester surgical abortions are performed with a paracervical block. Women may be unnecessarily exposed to a painful injection and potentially noxious medication. Our objective was to estimate the effect of a paracervical block and the effect of gestational age on patient pain perception.
This was a randomized, single-blind trial of patients undergoing abortion receiving paracervical block or sham stratified by gestational age (early: less than 8 weeks of gestation, n=60; late: 8-10 6/7 weeks of gestation, n=60). Premedicated with ibuprofen and lorazepam, all participants received 2 mL 1% buffered lidocaine injected at the tenaculum site followed by a slow, deep injection of 18 mL at four sites (block) or no injection (sham) with a 3-minute wait. The primary outcome was dilation pain (100-mm visual analog scale). Secondary outcomes included pain at additional time points, satisfaction, need for more analgesics, and adverse events.
Full enrollment occurred (n=120). We used intent-to-treat analysis. Demographics did not differ between groups. Paracervical block administration was painful (mean 55 mm compared with sham 30 mm, P<.001) but decreased dilation pain (42 mm compared with 79 mm, P<.001) and aspiration pain (63mm compared with 89 mm, P<.001). These results were consistent for both gestational age strata; however, paracervical block benefit was greater at an earlier gestation. Satisfaction scores with pain control and the procedure were significantly higher in the block group.
Although paracervical block is painful, it reduces first-trimester abortion pain regardless of gestational age, but the benefit on dilation pain was greater at earlier gestations.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094366.
I.
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Clinical trials have found misoprostol and nonsteroidal drugs to be ineffective (Am J Obstet Gynecol 2006;195:1272-1277, Hum Reprod 2011;26:323-329, Hum Reprod 2007;22:2647-2652). One study suggested that 2% lidocaine gel decreased pain; however, study design problems limit its validity (Brit J Fam Plann 1996;22:177-180). We tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.
We planned a randomized, double-blinded clinical trial of 200 women. We placed 2% lidocaine gel or placebo in the cervix prior to uterine sounding. Participants rated pain by marking a 100-mm visual analogue scale at four time points.
We randomized 200 participants and placed 197 IUDs. Pain was greatest at uterine sounding and similar between groups: placebo group mean 51.6 mm (SD 25), lidocaine group mean 55.5 mm (SD 30, p=.33). Stratified analyses accounting for parity showed no treatment effect. Multivariable analyses identified longer time since last pregnancy, lower parity and higher anticipated pain as predictors of pain during sounding, and dysmenorrhea and the levonorgestrel IUD as additional predictors during IUD insertion.
Intracervical 2% lidocaine gel does not decrease IUD insertion pain. Understanding predictors of increased pain may help providers with preprocedure counseling.
To identify an appropriate dose for a new contraceptive levonorgestrel intrauterine system (LNG-IUS).
Randomized, open-label, three-arm, phase II study.
Thirty-seven centers in five European countries.
Parous or nulliparous women aged 21-40 years.
Treatment with LNG-IUSs with initial in vitro release rates of 12 or 16 μg/d (LNG-IUS12/16) or 20 μg/d (Mirena).
Pearl index, bleeding profile, ease/pain of placement/removal, adverse events.
A total of 738 subjects had an LNG-IUS placed (LNG-IUS12, n = 239; LNG-IUS16, n = 245; Mirena, n = 254). One, 5, and 0 pregnancies occurred in the LNG-IUS12, LNG-IUS16, and Mirena groups, respectively (3-year unadjusted Pearl indices: 0.17, 0.82, and 0). The bleeding profiles were similar in all groups, although total bleeding and spotting days decreased with increasing LNG dose. During 3 years, 10 subjects in the LNG-IUS12 (2 women), LNG-IUS16 (3 women), and Mirena (5 women) groups reported serious adverse events, possibly related to study treatment. Placement of LNG-IUS12 and LNG-IUS16 was considered easy in 94% versus 86.2% in the Mirena group and 72.3% in the LNG-IUS12/LNG-IUS16 group reported either "no pain" or only "mild pain" during placement versus 57.9% in the Mirena group.
LNG-IUS12 and LNG-IUS16 provided effective contraception, acceptable bleeding patterns, and were well tolerated compared with Mirena.
Despite the high efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) in preventing pregnancy, uptake of the intrauterine devices remains low in the United States. Decreasing pain at the time of intrauterine device insertion may be one way to increase interest in this method of contraception.
We conducted a double-blind, placebo-controlled trial, randomizing women to 800 mg ibuprofen or placebo 45 min prior to LNG-IUS insertion to determine effect of ibuprofen on the pain of LNG-IUS insertion.
Eighty-one women completed the study: 44 received ibuprofen, and 37 received placebo. Women in the ibuprofen and placebo groups had similar mean scores for anticipated pain (4.07 and 3.91, respectively; p=.79), pain with tenaculum placement (3.86 and 3.81, respectively; p=.90) and pain with insertion (3.69 and 3.34, respectively; p=.91).
Administration of ibuprofen prophylaxis for LNG-IUS insertion does not decrease pain at the time of insertion.
This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women.
Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider "ease of placement" (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34.
A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported.
Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.
Designated providers in specialized clinics perform the majority of approximately 1.1 million first-trimester abortions carried out in the United States each year. Our objective was to assess the first-trimester surgical abortion practices of National Abortion Federation (NAF) members.
We mailed questionnaires to NAF administrators and providers at their 364 active-member facilities in 2002.
Two hundred eighty-nine (79%) facilities responded; we received administrative questionnaires from 273 facilities and 293 individual clinicians. NAF facilities provided at least 325,000 first-trimester surgical abortions in the United States in 2001. The majority of providers are obstetrician-gynecologists (63%), male (62%) and at least 50 years old (64%). Half of clinicians (49%) selectively utilize manual vacuum aspiration. Almost half (47%) routinely use a metal curette to verify procedure completion; these providers are more likely to be over 50 years of age or to have 20 years or more of abortion experience. Other practices are more uniform, including routine tissue examination (93%), postoperative antibiotics (88%) and contraceptive provision (oral contraceptives, 99%; depot medroxyprogesterone acetate, 79%).
Most perioperative practices for first-trimester abortions are similar among these respondents, in accord with evidence-based guidelines. The aging of skilled practitioners raises concerns about the future availability of surgical abortion.
The objectives of this study were to determine whether carbonated or plain lidocaine provides better pain control during abortions and to determine whether deep injections of lidocaine provide better pain control than regular injections of lidocaine.
Phase 1 was a prospective, randomized, double-blind trial comparing 10 cm3 of 2% carbonated lidocaine with plain lidocaine. In phase 2 the plain lidocaine group in phase 1 was compared prospectively with the next group of patients, in whom a new technique of deep injection was used. A pain scale was administered by the counselor after dilatation and at the end of the procedure.
The improvement in pain scores with carbonated lidocaine was 8%. The improvement with the deep injection technique was 25%.
The improvement in pain scores with deep injection was clinically significant and is recommended.
Topical benzocaine 20% gel was evaluated for its ability to reduce pain associated with several common gynecologic procedures. In the first phase of the investigation, designed to determine the efficacy of the gel, 40 women received it before one or more of five procedures (cervical biopsy, intrauterine device insertion, endocervical curettage, paracervical block, and tenaculum placement). These women reported significantly less pain than 42 control subjects (P less than .05 to P less than .0005). In the second phase of the study, a placebo gel was compared in a blind fashion with 20% benzocaine gel in 63 study subjects and 64 control women undergoing procedures similar to those in the first part of the study. The modal pain rating by both physician and patient was "none" in the study group for all procedures except endocervical curettage, for which the rating was "mild"; ratings were "mild" or "moderate" in the control group. Compliance with respect to keeping follow-up visits was significantly greater in the study group. These data indicate that benzocaine 20% significantly reduces the pain experienced by patients after many gynecologic procedures performed vaginally.
To determine the amount of change in pain severity, as measured by a visual analog scale, that constitutes a minimum clinically significant difference.
Patients 18 years of age or older who presented with acute pain resulting from trauma were enrolled in this prospective, descriptive study. The setting was an urban county hospital emergency department with a Level 1 trauma center. In the course of a brief interview, patients were asked to indicate their current pain severity with a single mark through a standard 100-mm visual analog scale. At intervals of 20 minutes for the next 2 hours, patients were asked to repeat this measurement and, in addition, to contrast their present pain severity with that at the time of the previous measurement. They were to indicate whether they had "much less," "a little less," "about the same," "a little more," or "much more" pain. All contrasts were made without reference to prior visual analog scale measurements. A maximum of six measurements of pain change were recorded per patient. Measurements ended when the patient left the ED or when the patient reported a pain score of zero. The minimum clinically significant change in visual analog scale pain score was defined as the mean difference between current and preceding visual analog scale scores when the subject noted a little less or a little more pain.
Forty-eight subjects were enrolled, and 248 pain contrasts were recorded. Of these contrasts, 41 were rated as a little less and 39 as a little more pain. The mean difference between current and preceding visual analog scale scores in these 80 contrasts was 13 mm (95% confidence interval, 10 to 17 mm).
The minimum clinically significant change in patient pain severity measured with a 100-mm visual analog scale was 13 mm. Studies of pain experience that report less than a 13-mm change in pain severity, although statistically significant, may have no clinical importance.
The present study was designed to investigate whether deep injections of local anesthetics provide better pain control than regular injections of local anesthetics, and to evaluate the influence of basal cervical dilatation and dilatation increase obtained on the painfulness of abortion procedure during legal abortions. A total of 66 women undergoing legal abortion were randomly allocated to treatment with deep injection (n = 31) or regular injection (n = 35) group. Subjects in the deep injection group had paracervical block involving four injections approximately 3 cm deep. Subjects assigned to the regular injection group had paracervical block involving four injections approximately 1.5 cm deep. A pain scale was administered at the end of the dilatation and end of curettage. Both groups were found to be similar with respect to age, parity, previous legal abortion, gestational age, anxiety score, procedure time, basal cervical dilatation, and dilatation increase obtained. The mean pain score during cervical dilatation was less for the deep injection versus the regular injection group (3.3 +/- 1.5 versus 4.0 +/- 1.6, p < 0.05). The mean pain score during curettage was significantly less for the deep injection versus the regular injection group (3.0 +/- 1.2 versus 3.9 +/- 1.4, p < 0.05). In conclusion, deep injection of local anesthetics is a safe adjunct in the management of legal abortion. Irrespective of injection technique, dilatation pain is correlated negatively with basal cervical dilatation and correlated positively with dilatation increase obtained.
In a double-blind, randomized, placebo-controlled study conducted at a contraception clinic, 55 women (three nulliparous) were given either ibuprofen 600 mg or placebo 1-4 hours prior to insertion of IUD, 4-6 hours after insertion of IUD and the following morning. Pain was assessed by ten point Numerical Rating Scales during insertion, in the first 4-6 hours and in the following three days. No benefit of ibuprofen was demonstrated at insertion or at any other time during the first three days. The patients were further randomized to type of IUD: TCu-380A and Nova T (R.). No difference in pain scores was evaluated between these.
To compare the efficacy of two modalities of local anesthesia for diagnostic hysteroscopy in different steps of the procedure in terms of pain control and time required for the examination.
One hundred eighty women undergoing diagnostic hysteroscopy were included in the study and randomly allocated to one of two groups. Group A (n = 88), treated with prilocaine plus lidocaine cream, and group B (n = 92), treated with lidocaine spray, were compared with group C, a control group (n = 165), including all the hysteroscopies performed without anesthesia in the same period. Duration of the hysteroscopic examination was recorded; intensity of pain induced by the procedure and shoulder pain 10 minutes after the end of the examination were recorded for all patients on the basis of a four-point pain scale.
Duration of the procedure required was two minutes in a significantly lower percentage of patients in group A as compared to groups B and C. Furthermore, in group A we found a significant reduction in pain at placement of the tenaculum in comparison to groups B and C. In groups A and B, no patient experienced a "very painful" grade of pain versus 4.8% in group C. The vasovagal reaction rate was also significantly lower in both treated groups in comparison to the control group. Furthermore, the intensity of shoulder pain was significantly lower in the group receiving prilocaine plus lidocaine cream as compared to the other two groups.
Local anesthesia has a beneficial effect, at least in those hysteroscopies presumed to be, for whatever reasons, more cumbersome to perform. Prilocaine plus lidocaine cream was more effective than lidocaine spray in decreasing pain at placement of the tenaculum and shoulder pain after the procedure.
Our purpose was to assess the effect on pain and patient satisfaction of waiting between paracervical block and dilation during first-trimester abortions.
One hundred ninety-nine women seeking pregnancy termination were randomly assigned to a no-wait group (group 1) and a 3- to 5-minute wait between injection and dilation group (group 2). Subjects rated their pain on a visual analog scale at four times: prior to procedure, with dilation, with aspiration, and 30 to 45 minutes after procedure.
No significant differences were observed in pain or satisfaction ratings reported by group 1 (n = 93) and group 2 (n = 101). A significant decrease in pain with dilation (1.21 cm decrease, P =.009) and aspiration (1.15 cm decrease, P =.0015) was observed among patients who received fentanyl.
Delay between paracervical injection and dilation during first-trimester abortion does not have an impact on patient pain or satisfaction. Fentanyl decreased pain scores by 20% to 25% during the procedure.
This study was undertaken to determine whether 400 mg of prophylactic ibuprofen can alleviate pain from insertion of an intrauterine device (IUD) and to measure level of pain with improved techniques.
We conducted a randomized, double-blind, placebo-controlled trial of 2019 first-time IUD users: 1008 women received placebo and 1011 women received 400 mg of ibuprofen. Participants took the single tablet at least 45 minutes before IUD insertion. Immediately after insertion, participants recorded level of pain by using a 10-cm visual analog scale, with the value of 10 meaning "worst imaginable pain."
Median level of pain was 1.0 for both ibuprofen and placebo participants; rank test statistics confirmed no difference. Some subgroups of women experienced higher pain (eg, nulliparous women), but ibuprofen still had no important impact on level of pain.
Even among first-time users, pain from IUD insertion is generally low. Prophylactic ibuprofen as used in this protocol does not reduce IUD insertion pain.
Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial
- Bednark