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Impact of standard-pressure and low-pressure pneumoperitoneum on shoulder pain following laparoscopic cholecystectomy: a randomised controlled trial

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Background: The incidence of shoulder pain (SP) following laparoscopic cholecystectomy (LC) varies between 21 and 80 %. A few randomised controlled trials and meta-analysis have shown lesser SP in LC performed under low-pressure carbon dioxide pneumoperitoneum (LPCP) than under standard-pressure carbon dioxide pneumoperitoneum (SPCP). However, the possible compromise in adequate exposure and effective working space during LPCP has negatively influenced its uniform adoption for LC. Materials and methods: All consecutive patients undergoing elective LC for gallstone disease who met the inclusion and exclusion criteria were enroled. Fourty patients were randomised to SPCP group (pressure of 14 mmHg) and 40 to LPCP group (pressure of 9-10 mmHg). Primary outcome measured was incidence of SP and its severity on visual analogue scale (VAS) at 4, 8, 24 h and 7 days after LC. Secondary outcomes measured were procedural time, technical difficulty, surgeons' satisfaction score on exposure and working space, intra-operative changes in heart rate and blood pressure, abdominal pain and analgesic requirement. Analyses were performed using Stata software. Results: There was no conversion to open surgery, bile duct injury or need to increase intra-abdominal pressure on either group. Twenty-three patients (57.5 %) in SPCP group and nine patients (22.5 %) in LPCP group had SP (p = 0.001). The severity of SP was significantly more in SPCP group at 8 and 24 h (p = 0.009 and 0.005, respectively). Both the groups had similar procedural time, surgeons' satisfaction score, intra-operative changes in heart rate and blood pressure. Conclusion: The incidence and severity of SP following LC performed at LPCP are significantly less compared to that in SPCP. The safety, efficacy and surgeons' satisfaction appear to be comparable in both the groups. Hence, a routine practice of low-pressure carbon dioxide pneumoperitoneum may be recommended in selected group of patients undergoing laparoscopic cholecystectomy. Clinical trial registration number: CTRI/2016/02/006590.
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Impact of standard-pressure and low-pressure
pneumoperitoneum on shoulder pain following laparoscopic
cholecystectomy: a randomised controlled trial
Hemanga K. Bhattacharjee
1
Azarudeen Jalaludeen
1
Virinder Bansal
1
Asuri Krishna
1
Subodh Kumar
1
Rajeshwari Subramanium
2
Rashmi Ramachandran
2
Mahesh Misra
1
Received: 16 March 2016 / Accepted: 9 July 2016 / Published online: 21 July 2016
ÓSpringer Science+Business Media New York 2016
Abstract
Background The incidence of shoulder pain (SP) follow-
ing laparoscopic cholecystectomy (LC) varies between 21
and 80 %. A few randomised controlled trials and meta-
analysis have shown lesser SP in LC performed under low-
pressure carbon dioxide pneumoperitoneum (LPCP) than
under standard-pressure carbon dioxide pneumoperitoneum
(SPCP). However, the possible compromise in adequate
exposure and effective working space during LPCP has
negatively influenced its uniform adoption for LC.
Materials and methods All consecutive patients undergo-
ing elective LC for gallstone disease who met the inclusion
and exclusion criteria were enroled. Fourty patients were
randomised to SPCP group (pressure of 14 mmHg) and 40
to LPCP group (pressure of 9–10 mmHg). Primary out-
come measured was incidence of SP and its severity on
visual analogue scale (VAS) at 4, 8, 24 h and 7 days after
LC. Secondary outcomes measured were procedural time,
technical difficulty, surgeons’ satisfaction score on expo-
sure and working space, intra-operative changes in heart
rate and blood pressure, abdominal pain and analgesic
requirement. Analyses were performed using Stata
software.
Results There was no conversion to open surgery, bile duct
injury or need to increase intra-abdominal pressure on
either group. Twenty-three patients (57.5 %) in SPCP
group and nine patients (22.5 %) in LPCP group had SP
(p=0.001). The severity of SP was significantly more in
SPCP group at 8 and 24 h (p=0.009 and 0.005, respec-
tively). Both the groups had similar procedural time, sur-
geons’ satisfaction score, intra-operative changes in heart
rate and blood pressure.
Conclusion The incidence and severity of SP following LC
performed at LPCP are significantly less compared to that
in SPCP. The safety, efficacy and surgeons’ satisfaction
appear to be comparable in both the groups. Hence, a
routine practice of low-pressure carbon dioxide pneu-
moperitoneum may be recommended in selected group of
patients undergoing laparoscopic cholecystectomy.
Clinical trial registration number CTRI/2016/02/006590.
Keywords Laparoscopic cholecystectomy Shoulder
pain Low-pressure pneumoperitoneum Standard-
pressure pneumoperitoneum Surgeons’ satisfaction
Presented at the SAGES 2016 Annual Meeting, March 16–19, 2016,
Boston, Massachusetts.
&Virinder Bansal
drvkbansal@gmail.com
Hemanga K. Bhattacharjee
dr_hkb75@yahoo.com
Azarudeen Jalaludeen
azrudn@gmail.com
Asuri Krishna
dr.asurikrishna@gmail.com
Subodh Kumar
subodh6@gmail.com
Rajeshwari Subramanium
drsrajeshwari@gmail.com
Rashmi Ramachandran
rashmiramachandran1@gmail.com
Mahesh Misra
mcmisra@gmail.com
1
Department of Surgical Disciplines, All India Institute of
Medical Sciences, New Delhi, India
2
Department of Anaesthesiology, All India Institute of
Medical Sciences, New Delhi, India
123
Surg Endosc (2017) 31:1287–1295
DOI 10.1007/s00464-016-5108-2
and Other Interventional Techniques
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... In terms of postoperative pain studies have demonstrated LPP has better pain score and lower incidence of shoulder pain than SPP in laparoscopic cholecystectomy [28] and it has been demonstrated use of deep NMB further reduces postoperative pain and incidence of shoulder pain. In our study however, we did not find any clinically significant difference in pain outcomes in terms of postoperative pain scores or incidence of shoulder pain. ...
... A standardization of reporting may be considered in future studies. The scoring used here was part of previous study from our institute and was standardized for laparoscopic cholecystectomy [28]. ...
Article
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Background Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB. Methodology This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8-10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1-2] and Group B: SPP; 12-14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported. Results Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable. Conclusion LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.
... In terms of postoperative pain studies have demonstrated LPP has better pain score and lower incidence of shoulder pain than SPP in laparoscopic cholecystectomy [28] and it has been demonstrated use of deep NMB further reduces postoperative pain and incidence of shoulder pain. In our study however, we did not find any clinically significant difference in pain outcomes in terms of postoperative pain scores or incidence of shoulder pain. ...
... A standardization of reporting may be considered in future studies. The scoring used here was part of previous study from our institute and was standardized for laparoscopic cholecystectomy [28]. ...
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Background Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB. Methodology This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8–10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1–2] and Group B: SPP; 12–14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported. Results Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable. Conclusion LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.
... Shoulder pain: Thirteen studies [10][11][12]19,20,23,24,27,29,32,34,[39][40][41][42] including 1036 patients reported shoulder pain outcomes. Of the 505 patients in the LAP group, 104 patients suffered shoulder pain. ...
... Analgesic use was reported in nine studies [10,12,17,22,23,32,36,39] including 646 patients. Of the 326 patients in the LAP group, 100 used analgesics. ...
Article
Background: This study aimed to comprehensively evaluate the impact of low- and standard-abdominal pressure on intraoperative, postoperative, and survival outcomes of Laparoscopic Cholecystectomy (LC). Methods: A literature search of the databases, PubMed, Web of Science, Embase, and Cochrane Library was performed until April 30, 2021. Studies comparing low abdominal pressure and standard abdominal pressure for LC were included. Two reviewers independently screened the studies, extracted the data of interest, and assessed the risk of bias. Meta-analysis was performed using RevMan 5.3.
... Low pressure pneumoperitoneum 4] has been challenging the complications and feasibility of standard pressure pneumoperitoneum [5,6]. Clinical trials have compared low pressure vs. standard in terms of perioperative complications, post-operative pain, hospital length of stay, stress response and surgeon comfort [6,7]. In this trail we conducted a randomized comparison between low pressure and standard pressure pneumoperitoneum for laparoscopic cholecystectomy in terms of postoperative pain, inflammatory markers, timing of surgery and surgeon comfort. ...
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Full-text available
Objective We aim to assess the effect of low-pressure pneumoperitoneum on post operative pain and ten of the known inflammatory markers. Background The standard of care pneumoperitoneum set pressure in laparoscopic cholecystectomy is set to 12–14 mmHg, but many societies advocate to operate at the lowest pressure allowing adequate exposure of the operative field. Many trials have described the benefits of operating at a low-pressure pneumoperitoneum in terms of lower post operative pain, and better hemodynamic stability. But only few describe the effects on inflammatory markers and cytokines. Methods A prospective, double-blinded, randomised, controlled clinical trial, including patients who underwent elective laparoscopic cholecystectomy. Patients randomised into low-pressure (8–10 mmHg) vs. standard-pressure (12–14 mmHg) with an allocation ratio of 1:1. Perioperative variables were collected and analysed. Results one hundred patients were allocated, 50 patients in each study arm. Low-pressure patients reported lower median pain score 6-hour post operatively (5 vs. 6, p-value = 0.021) in comparison with standard-pressure group. Eight out of 10 inflammatory markers demonstrated better results in low-pressure group in comparison with standard-pressure, but the effect was not statistically significant. Total operative time and surgery difficulty was not significantly different between the two groups even in the hands of inexperienced surgeons. Conclusion low-pressure laparoscopic cholecystectomy is associated with less post operative pain and lower rise of inflammatory markers. It is feasible with comparable complications to the standard of care. Registered on ClinicalTrials.gov (NCT05530564/ September 7th, 2022).
... El riesgo relativo de presentar dolor fue de 2.7 (IC 95% 1.4, 5.0) con la presión alta. 25 Estos hallazgos sugieren que la fisiopatología del dolor está relacionada con la presión a la que es Otro ensayo clínico controlado, con 160 pacientes divididos en dos grupos, demostró que el grupo sometido a presiones menores de 10 mmHg (comparado con > de 10 mmHg) presentó menos frecuencia de dolor (7.5 vs 23.8%, p = 0.005) y disminución en la intensidad de dolor en una escala visual análoga de 0.28 ± 0.90 vs 1.31 ± 2.30, p = 0.001). No obstante, llama la atención que la incidencia total de dolor de hombros en ambos grupos fue sólo de 15%, lo cual indica que aun usando presiones mayores de 10 mmHg, son pocos los pacientes que presentaron dolor. ...
... 5,6 Clinical trials have compared low pressure vs. standard in terms of perioperative complications, post-operative pain, hospital length of stay, stress response and surgeon comfort. 6,7 In this trail we conducted a randomized comparison between low pressure and standard pressure pneumoperitoneum for laparoscopic cholecystectomy in terms of postoperative pain, in ammatory markers, timing of surgery and surgeon comfort. This trial adds to the literature the extensive study of in ammatory markers associated with stress of surgery, and the surgeon comfort level along with safety of the procedure with performed by non-experienced surgeons (senior residents). ...
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Full-text available
Objective We aim to assess the effect of low-pressure pneumoperitoneum on post operative pain and ten of the known inflammatory markers. Background The standard of care pneumoperitoneum set pressure in laparoscopic cholecystectomy is set to 12–14 mmHg, but many societies advocate to operate at the lowest pressure allowing adequate exposure of the operative field. Many trials have described the benefits of operating at a low-pressure pneumoperitoneum in terms of lower post operative pain, and better hemodynamic stability. But only few describe the effects on inflammatory markers and cytokines. Methods A prospective, double-blinded, randomised, controlled clinical trial, including patients who underwent elective laparoscopic cholecystectomy. Patients randomised into low-pressure (8–10 mmHg) vs. standard-pressure (12–14 mmHg) with an allocation ratio of 1:1. Perioperative variables were collected and analysed. Registered on ClinicalTrials.gov (NCT05530564/ September 7th, 2022). Results one hundred patients were allocated, 50 patients in each study arm. Low-pressure patients reported lower median pain score 6-hour post operatively (5 vs 6, p-value = 0.021) in comparison with standard-pressure group. Eight out of 10 inflammatory markers demonstrated better results in low-pressure group in comparison with standard-pressure, but the effect was not statistically significant. Total operative time and surgery difficulty was not significantly different between the two groups even in the hands of inexperienced surgeons. Conclusion low-pressure laparoscopic cholecystectomy is associated with less post operative pain and lower rise of inflammatory markers. It is feasible with comparable complications to the standard of care.
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To evaluate the efficacy of combined infiltrative bupivacaine with low intraperitoneal pressure insufflation in reducing the post-laparoscopic pain in patients undergoing laparoscopic cholecystectomy (LC). This randomized prospective single-blind study included 473 patients undergoing LC. The study took place at University Hospital Center Mother Teresa, Tirana, Albania between January 2006 to September 2009. The patients were divided in 4 groups: Group 1 (n=120) with intra-abdominal insufflation pressure 15 mm Hg and no infiltrative bupivacaine (HPNBG); Group 2 (n=122) with intra-abdominal insufflation pressure 15 mm Hg and with 5 ml infiltrative bupivacaine 0.5% in abdominal minincisions (HPBG); Group 3 (n=110) with intra-abdominal insufflation pressure under 10 mm Hg and no infiltrative bupivacaine (LPNBG); and Group 4 (n=121) with intra-abdominal insufflation pressure under 10 mm Hg and infiltrative bupivacaine (LPBG). There were statistically significant differences (p=0.003) between groups regarding incisional pain intensity, between LPBG and HPNBG (p=0.001), between LPBG and HPBG (p=0.037), between LPBG and LPNBG (p=0.001), as well the shoulder-tip pain intensity (p=0.001); between LPBG and HPNBG (p=0.001), between LPBG and HPBG (p=0.001), and between LPBG and LPNBG (p=0.031). We found statistically significant differences related to pain beginning time (ANOVA test, p=0.027); between LPBG and HPNBG (p=0.041), between LPBG and HPBG (p=0.031), and between LPBG and LPNBG (p=0.05). The combination of infiltrative bupivacaine with low intraperitoneal pressure insufflation shows to be more efficient in reducing the post-laparoscopic pain, compared with other regimens.
Article
To evaluate the effectiveness of the pulmonary recruitment maneuver (PRM) and intraperitoneal normal saline infusion (INSI) in removing postlaparoscopic carbon dioxide from the abdominal cavity to decrease laparoscopy-induced abdominal or shoulder pain after surgery. Design, Setting, and A prospective, randomized, controlled trial was conducted at Taipei Veterans General Hospital, Taipei, Taiwan, from August 1, 2009, through June 30, 2010. One hundred fifty-eight women undergoing laparoscopic surgery for benign gynecologic lesions were randomly assigned to 3 groups: the PRM group (n = 53), the INSI group (n = 54), and the control group (n = 51). Postoperative maneuvers included PRM and INSI. Evaluation of pain, including abdominal pain and shoulder pain, was performed at 12, 24, and 48 hours postoperatively. The frequency of postoperative shoulder pain at 24 and 48 hours was significantly decreased in the INSI group compared with that of either the PRM or control group (40.7% and 24.1% in the INSI group vs 66.0% and 50.9% in the PRM group [P = .009 and .004, respectively] or vs 72.5% and 54.9% in the control group [both P < .001]). Both methods significantly reduced the frequency of upper abdominal pain compared with the control condition (73.6% in the PRM group at 24 hours [P = .03] or 72.2% at 24 hours [P .02] and 44.4% at 48 hours [P = .01] in the INSI group vs 90.2% at 24 hours and 68.6% at 48 hours in the control group). Both PRM and INSI could effectively reduce pain after laparoscopic surgery, but INSI might be better for both upper abdominal and shoulder pain.
Article
Laparoscopic cholecystectomy (LC) has become the standard treatment for gall bladder disease. However, despite its low degree of invasiveness, many patients complain of postoperative pain and postoperative nausea/vomiting. This study was planned to evaluate different factors affecting the incidence and severity of postoperative shoulder-tip pain after LC. One hundred consecutive patients who were treated for gall bladder stone by LC at the Gastroenterology Surgical Center, Mansoura University, Mansoura, Egypt, during the period from October 2008 to January 2010, were randomized according to different pnemoperitonum pressures (8, 10, 12, and 14 mm Hg). Each group comprises 25 patients. There were 62 patients reported to have postoperative shoulder-tip pain during the first 12 hours after operation, which decreased to 9 patients on the 10th postoperative day. A significant difference was observed in the prevalence of pain at different pressures, 11% with low pressure and increased to 20% with high pressure. The incidence of shoulder-tip pain was significantly more in patients with a longer duration of the operation of >45 minutes at 12 hours (23 [76.7%] versus 39 [55.7%]; P = 0.04), at 24 hours (23 [76.7%] versus 29 [41.4%]; P = 0.009), and at 3 days postoperatively (19 [63.3%] versus 20 [28.6%]; P = 0.01). The volume of used gases during the operation had no effect on the incidence or severity of shoulder-tip pain after LC. Also, the use of intraoperative analgesics had no effect on the incidence or severity of shoulder-tip pain after LC. The origin of pain after LC is multifactorial. We recommend the use of the lower pressure technique during LC, and as patients with and without drains have similar incidence of postoperative shoulder pain, drains should not be used with the intention of preventing shoulder pain.