Eugene R Viscusi

Thomas Jefferson University, Filadelfia, Pennsylvania, United States

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Publications (121)306.4 Total impact

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    ABSTRACT: Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. The American Pain Society, with input from the American Society of Anesthesiologists, commissioned an interdisciplinary expert panel to develop a clinical practice guideline to promote evidence-based, effective, and safer postoperative pain management in children and adults. The guideline was subsequently approved by the American Society for Regional Anesthesia. As part of the guideline development process, a systematic review was commissioned on various aspects related to various interventions and management strategies for postoperative pain. After a review of the evidence, the expert panel formulated recommendations that addressed various aspects of postoperative pain management, including preoperative education, perioperative pain management planning, use of different pharmacological and nonpharmacological modalities, organizational policies, and transition to outpatient care. The recommendations are based on the underlying premise that optimal management begins in the preoperative period with an assessment of the patient and development of a plan of care tailored to the individual and the surgical procedure involved. The panel found that evidence supports the use of multimodal regimens in many situations, although the exact components of effective multimodal care will vary depending on the patient, setting, and surgical procedure. Although these guidelines are based on a systematic review of the evidence on management of postoperative pain, the panel identified numerous research gaps. Of 32 recommendations, 4 were assessed as being supported by high-quality evidence, and 11 (in the areas of patient education and perioperative planning, patient assessment, organizational structures and policies, and transitioning to outpatient care) were made on the basis of low-quality evidence.
    Full-text · Article · Feb 2016
  • Eugene R Viscusi
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    ABSTRACT: The need for better post-surgical pain management continues to be unmet, despite clinicians' awareness and concern for many years. Opioids remain the standard of care because of their analgesic efficacy; however, opioid use is often associated with adverse effects and poor patient outcomes. Multimodal analgesic regimens have recently been endorsed as a way to provide adequate post-surgical pain control while reducing opioid consumption. Liposome bupivacaine is a liposomal formulation of bupivacaine indicated for a single administration into the surgical site. Based on the available clinical trial data compiled to date, as well as the author's review of publicly available post-marketing safety information, liposome bupivacaine may be a viable addition to currently available therapeutic options for post-surgical analgesia while reducing potential risks associated with use of opioid analgesics, and may represent a useful addition to the multimodal analgesic modalities currently used for post-operative pain management. The potential for its use in other areas is also being investigated. The purpose of this review is to examine the currently available post-marketing safety information on liposome bupivacaine.
    No preview · Article · Oct 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Chronic postsurgical pain (CPSP) is a distressing disease process that can lead to long-term disability, reduced quality of life, and increased health care spending. Although the exact mechanism of development of CPSP is unknown, nerve injury and inflammation may lead to peripheral and central sensitization. Given the complexity of the disease process, no novel treatment has been identified. The preoperative use of multimodal analgesia has been shown to decrease acute postoperative pain, but it has no proven efficacy in preventing development of CPSP.
    No preview · Article · Oct 2015 · Medical Clinics of North America
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    ABSTRACT: Objective: This analysis compared opioid-related adverse events (ORADEs) observed with fentanyl iontophoretic transdermal system (ITS) versus morphine intravenous (iv.) patient-controlled analgesia (PCA) in the management of postoperative pain. Methods: Safety data from four Phase IIIB randomized, active-comparator trials were pooled for this analysis (n = 1288 fentanyl ITS and 1313 morphine iv. PCA patients). Treatment-emergent adverse events were collected via spontaneous report. In this post hoc analysis, ORADEs were defined as apnea, confusion, constipation, dyspnea, hypotension, hypoventilation, hypoxia, ileus, nausea, pruritus, somnolence, tachycardia, urinary retention and vomiting. Odds ratios (OR) and 95% CI were calculated for all ORADEs and p-values were based on logistic regression with treatment as effect. Results: There were fewer patients in the fentanyl ITS group compared with the morphine iv. PCA group who experienced at least one ORADE (52.7 vs 59.1%, respectively; OR: 0.772: 95% CI: 0.661-0.901; p = 0.0011). The ORADEs that occurred less frequently in the fentanyl ITS group than in the morphine iv. PCA group included hypotension (3.7 vs 5.5%, respectively; OR: 0.667; 95% CI: 0.459-0.969; p = 0.0338), hypoventilation (0.9 vs 1.9%, respectively; OR: 0.444; 95% CI: 0.217-0.906; p = 0.0256), nausea (40.3 vs 44.5%, respectively; OR: 0.842; 95% CI: 0.721-0.984; p = 0.0310), pruritus (5.5 vs 9.4%, respectively; OR: 0.559; 95% CI: 0.413-0.757; p = 0.0002) and tachycardia (1.6 vs 2.8%, respectively; OR: 0.489; 95% CI: 0.277-0.863; p = 0.0136). No ORADEs occurred more frequently in the fentanyl ITS group compared with the morphine iv. PCA group. Conclusion: Fentanyl ITS, in the management of acute postoperative pain, offered safety advantages in terms of ORADEs compared with morphine iv. PCA.
    No preview · Article · Sep 2015
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    ABSTRACT: Efficacy of conventional opioids can be limited by adverse events (AEs). TRV130 is a structurally novel biased ligand of the μ-opioid receptor that activates G protein signaling with little β-arrestin recruitment. In this phase 2, randomized, placebo- and active-controlled study, we investigated the efficacy and tolerability of TRV130 in acute pain after bunionectomy. We used an adaptive study design in which 144 patients experiencing moderate-to-severe acute pain after bunionectomy were randomized to receive double-blind TRV130, placebo, or morphine in a pilot phase. After pilot phase analysis, 195 patients were randomized to receive double-dummy TRV130 0.5, 1, 2, or 3 mg every 3 hours (q3h); placebo; or morphine 4 mg q4h intravenously. The primary end point was the time-weighted average change in numeric rating scale pain intensity over the 48-hour treatment period. Secondary end points included stopwatch and categorical assessments of pain relief. Safety and tolerability were also assessed. TRV130 2 and 3 mg q3h, and morphine 4 mg q4h produced statistically greater mean reductions in pain intensity than placebo over 48 hours (P < 0.005). TRV130 at 2 and 3 mg produced significantly greater categorical pain relief than morphine (P < 0.005) after the first dose, with meaningful pain relief occurring in under 5 minutes. TRV130 produced no serious AEs, with tolerability similar to morphine. These results demonstrate that TRV130 rapidly produces profound analgesia in moderate-to-severe acute pain, suggesting that G-protein-biased μ-opioid receptor activation is a promising target for development of novel analgesics.
    Full-text · Article · Sep 2015 · Pain
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    ABSTRACT: This meta-analysis was conducted to analyze and compare the efficacy outcomes associated with the fentanyl iontophoretic transdermal system (ITS) and morphine intravenous (IV) patient-controlled analgesia (PCA) in the management of postoperative pain. This meta-analysis assessed the efficacy of the fentanyl ITS versus morphine IV PCA using data from four randomized, active-controlled trials (n = 1271 fentanyl ITS and 1298 morphine IV PCA patients). Main outcome measures were patient global assessment (PGA) of the method of pain control at 24 h. Fentanyl ITS and morphine IV PCA did not significantly differ regarding 'good' and 'excellent' ratings on the PGA of the method of pain control at 24 h (odds ratio = 0.95, p = 0.66), however, fentanyl ITS was superior in terms of 'excellent' PGA ratings at that time point (odds ratio = 1.53, p < 0.0001). No significant differences were found in weighted mean pain intensity scores at 24, 48 and 72 h. In this meta-analysis, fentanyl ITS was as efficacious as morphine IV PCA and may offer additional benefits as demonstrated by its 'excellent' PGA ratings.
    No preview · Article · Jun 2015 · Expert Opinion on Pharmacotherapy
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    ABSTRACT: There is concern that neuraxial anesthesia in patients undergoing surgery for treatment of a periprosthetic joint infection (PJI) may increase the risk of having a central nervous system infection develop. However, the available data on this topic are limited and contradictory. We wished to determine whether neuraxial anesthesia (1) is associated with central nervous system infections in patients undergoing surgery for a PJI, and (2) increases the likelihood of systemic infection in these patients. All 539 patients who received neuraxial or general anesthesia during 1499 surgeries for PJI from October 2000 to May 2013 were included in this study; of these, 51% (n = 764) of the surgeries were performed in 134 patients receiving neuraxial anesthesia and 49% were performed in 143 patients receiving general anesthesia. Two hundred sixty-two patients received general and neuraxial anesthesia during different surgeries. We used the International Classification of Diseases, 9(th) Revision codes and the medical records to identify patients who had an intraspinal abscess or meningitis develop after surgery for a PJI. Multivariate analysis was used to assess the effect of type of anesthesia (neuraxial versus general) on postoperative complications. There were no cases of meningitis, but one epidural abscess developed in a patient after neuraxial anesthesia. This patient underwent six revision surgeries during a 42-day period. Patients who received neuraxial anesthesia had lower odds of systemic infections (4% versus 12%; odds ratio, 0.35; 95% CI, 023-054; p < 0.001). Central nervous system infections after neuraxial anesthesia in patients with a PJI appear to be exceedingly rare. Based on the findings of this study, it may be time for the anesthesiology community to reevaluate the risk of sepsis as a relative contraindication to the use of neuraxial anesthesia. Level III, therapeutic study.
    Full-text · Article · Feb 2015 · Clinical Orthopaedics and Related Research
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    ABSTRACT: Purpose The literature and clinical data support the use of intravenous (IV) infusions of ibuprofen to control pain and reduce the opioid requirements associated with surgical pain. According to current guidelines, IV ibuprofen can be administered via a slow IV infusion performed during a 30-minute period. Although recent studies indicate that more rapid infusions may yield additional benefits for patients, the safety of such an approach needs further evaluation. The main purpose of this study was to determine the safety of single and multiple doses of IV ibuprofen (800 mg) administered over 5 to 10 minutes at the induction of anesthesia and after the surgical procedure for the treatment of postoperative pain. Methods This was a Phase IV, multicenter, open-label, clinical surveillance study. It was conducted at 21 hospitals in the United States, and 300 adult hospitalized patients undergoing surgery were enrolled. The exclusion criteria for the study were: inadequate IV access; hypersensitivity to any component of IV ibuprofen, aspirin, or related products; and any active, clinically significant bleeding. Also excluded were patients who had taken NSAIDs <6 hours before administration of IV ibuprofen; pregnant or breastfeeding female patients; and patients in the perioperative period of coronary artery bypass graft surgery. Patients received 800 mg of IV ibuprofen administered over 5 to 10 minutes preoperatively. Vital signs, adverse events, and pain scores were assessed. Findings Approximately 22% (65 of 300) of patients reported adverse events (serious and nonserious). The most common adverse event was infusion site pain (34 of 300 [11%]). No deaths were reported. Nine subjects reported serious adverse events, 8 of which occurred during the first 6 hours. All serious events reported were judged unrelated to ibuprofen. Of the 300 total patients, 2 (0.67%) discontinued the study drug due to an adverse event (1 patient discontinued the study because of infusion site pain, and 1 patient withdrew due to a hypersensitivity reaction after drug administration). Implications Our study found that IV ibuprofen infused over 5 to 10 minutes at induction of anesthesia is a safe administration option for surgical patients. ClinicalTrials.gov identifier: NCT01334957.
    Full-text · Article · Feb 2015
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    Charles V Pollack · Eugene R Viscusi
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    ABSTRACT: Abstract Undertreatment of pain (oligoanalgesia) in the emergency department is common, and it negatively impacts patient care. Both failure of appropriate pain assessment and the potential for unsafe analgesic use contribute to the problem. As a result, achieving satisfactory analgesia while minimizing side effects remains particularly challenging for emergency physicians, both in the emergency department and after a patient is discharged. Improvements in rapid pain assessment and in evaluation of noncommunicative populations may result in a better estimation of which patients require analgesia and how much pain is present. New formulations of available treatments, such as rapidly absorbed, topical, or intranasal nonsteroidal anti-inflammatory drug formulations or intranasal opioids, may provide effective analgesia with an improved risk-benefit profile. Other pharmacological therapies have been shown to be effective for certain pain modalities, such as the use of antidepressants for musculoskeletal pain, γ-aminobutyric acid agonists for neuropathic and postsurgical pain, antipsychotics for headache, and topical capsaicin for neuropathic pain. Nonpharmacological methods of pain control include the use of electrical stimulation, relaxation therapies, psychosocial/manipulative therapies, and acupuncture. Tailoring of available treatment options to specific pain modalities, as well as improvements in pain assessment, treatment options, and formulations, may improve pain control in the emergency department setting and beyond.
    Full-text · Article · Jan 2015 · Hospital practice (1995)
  • Eric S. Schwenk · Jaime L. Baratta · Kishor Gandhi · Eugene R. Viscusi
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    ABSTRACT: Successful implementation of an acute pain management service involves a team approach in which team members have clearly defined roles. Clinical protocols are designed to help address common problems and prevent errors. As the complexity of surgery and patients' diseases continues to increase, current knowledge of new analgesic medications, acute pain literature, and skills in regional anesthesia techniques is imperative. Emphasizing a multimodal approach can improve analgesia and decrease opioid-related side effects. Copyright © 2014 Elsevier Inc. All rights reserved.
    No preview · Article · Dec 2014 · Anesthesiology Clinics
  • Jaime L Baratta · Eric S Schwenk · Eugene R Viscusi
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    ABSTRACT: Uncontrolled postoperative pain may result in significant clinical, psychological, and socioeconomic consequences. Not only does inadequate pain management following surgery result in increased morbidity and mortality but it also may delay recovery, result in unanticipated readmissions, decrease patient satisfaction, and lead to chronic persistent postsurgical pain. Pain is multifactorial in nature, and understanding both the complexity of pain and its side effects is imperative to achieving a successful surgical outcome. In this section, we review the consequences of pain as they pertain to plastic surgery with a focus on the impact of pain on the surgical stress response and risk of wound infections and the effect of improved pain control on flap surgery. Uncontrolled acute postoperative pain may lead to chronic persistent postsurgical pain, which has a high incidence in patients undergoing breast cancer surgery. To achieve optimal postoperative analgesia, one must recognize the barriers to effective pain management, including both physician/nursing-related barriers and patient-related barriers, as well as the increasingly common appearance of opioid-tolerant patients.
    No preview · Article · Oct 2014 · Plastic & Reconstructive Surgery
  • Charles E Argoff · Eugene R Viscusi
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    ABSTRACT: Chronic noncancer pain is common and consequential, affecting ∼100 million people in the United States alone and costing, when direct and indirect costs are combined, in excess of $635 billion. For certain individuals, opioids may be an effective option for the management of chronic pain; however, a series of critical decisions must be made before prescribing opioids to ensure that their potential benefits and possible risks are appropriately and realistically addressed. A thorough history, physical examination, and appropriate testing, including an assessment of risk for substance abuse, misuse, or addiction, should be conducted in patients who are being considered for opioid therapy. Proactively developing a treatment plan that matches the needs and expectations of the patient, while minimizing the potential for substance abuse, is central to the success of pain management. Current standard of care suggests that for most patients, a trial of nonopioid therapies should generally be tried first. There is no single opioid of choice that universally provides the best outcomes for all patients; thus, it is critical for the health-care practitioner to become familiar with the available subclasses, formulations, and modes of administration, and base the treatment plan on clinical experience with the drug, prior patient experience, the availability of the formulation, and cost and coverage. Pain is a dynamic phenomenon in that its characteristics and response to treatment evolve over time, as does the patient's general health state. Both positive and negative changes over time may necessitate a change in medication. Opioids can be prescribed safely and effectively, and when used with appropriate attention to individual patient characteristics may have a positive impact on pain and function. When contemplating initiation of opioid analgesics, clinicians would do well to make it clear to their patient that they will be prescribed on a trial basis with a clear exit strategy for discontinuing such treatment if there is no clear benefit including lack of analgesia, insurmountable adverse effects, and/or frank misuse or abuse of the prescribed drug.
    No preview · Article · Sep 2014 · The American Journal of Gastroenterology
  • David A Provenzano · Eugene R Viscusi
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    ABSTRACT: Objective: Opioid analgesics are commonly and increasingly prescribed by physicians for the management of chronic pain. However, strong evidence supports the need for strategies that reduce opioid use. The objective of this review is to outline limitations associated with opioid use and discuss therapeutic techniques that can be adopted to optimize the use of opioids in the management of chronic nonmalignant pain. Scope: Literature searches through MEDLINE and Cochrane databases were used to identify relevant journal articles. The search was limited to articles published from January 1980 to January 2014. Additional references were obtained from articles extracted during the database search. Relevant search terms included opioid, opioid abuse, chronic pain management, written care agreements, urine drug testing, and multimodal therapy. Findings: Opioids exhibit a well established abuse potential and evidence supporting the efficacy of opioids in chronic pain management is limited. In addition, opioid exposure is associated with adverse effects on multiple organ systems. Effective strategies designed to mitigate opioid abuse and diversion and optimize clinical outcomes should be employed. Conclusions: Appropriate patient selection through identification of risk factors, urine drug testing, and access to prescription monitoring programs has been shown to effectively improve care. Structured opioid therapy in a multimodal platform, including use of a low initial dose, prescription of alternative non-opioid analgesics including non-steroidal anti-inflammatory drugs and acetaminophen, as well as development of written care agreements to individualize and guide therapy has also been shown to improve patient outcomes. Implementation of opioid allocation strategies has the potential to encourage appropriate opioid use and improve patient care.
    No preview · Article · May 2014 · Current Medical Research and Opinion
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    ABSTRACT: Introduction: Recently, multimodal pain control has been used to manage postoperative pain in patients undergoing total knee arthroplasty (TKA). This approach combines numerous modalities, such as opioids, nonsteroidal anti-inflammatory drugs, local anesthetics, and acetaminophen, in an effort to reduce overall opioid consumption and also to provide better pain control. Gabapentinoids are a class of drugs that have been used as part of multimodal approach, and may be effective in patients who are previous users of chronic pain medication. The hypothesis of this study was that the addition of pregabalin reduces opioid consumption and/or improves pain after TKA, even in patients who are previous users of chronic pain medications. Methods: Using a prospectively collected database, 262 consecutive patients undergoing primary TKA between December 2011 and April 2012 were identified who received multimodal analgesia after surgery that included pregabalin. Using the same database, these patients were compared with 268 patients undergoing TKA from January to December 2010 who also received multimodal analgesia but were not given pregabalin. The clinical records of these patients were reviewed in detail to determine the incidence and nature of postoperative complications, opioid consumption, and visual analog scale (VAS) pain scores. Results: The incidence of respiratory, renal, and hemodynamic complications was significantly lower in the patients who received pregabalin. Gastrointestinal complications, which included nausea, were not significantly different between the groups. Patients receiving pregabalin had a lower average opioid consumption, and their minimum and maximum levels of opioid consumption were also reduced. Previous users of chronic pain medications had higher VAS scores but the same opioid consumption compared with those who were not previous users of chronic pain medications. No difference was seen in the maximum VAS scores between patients who received pregabalin and those who did not. Conclusion: Pregabalin in the context of multimodal pain management may be associated with reduced opioid consumption and other medical complications in patients undergoing TKA, including previous users of chronic pain medications.
    Full-text · Article · May 2014 · The Physician and sportsmedicine
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    ABSTRACT: Background and objectives: In patients with chronic noncancer pain, subcutaneous methylnaltrexone for opioid-induced constipation (OIC) was examined in a randomized controlled trial (RCT) followed by an open-label extension (OLE). This study examined the reproducibility of RCT findings by analyzing data from placebo-treated patients who crossed over to methylnaltrexone. Methods: Adults with less than 3 weekly rescue-free bowel movements (RFBMs), taking 50 mg or more of an oral morphine equivalent per day, were randomized to receive methylnaltrexone 12 mg or placebo for 4 weeks, followed by open-label methylnaltrexone 12 mg as needed for 8 weeks. Results: A total of 134 placebo-treated patients (median morphine equivalent dose, 150 mg/d; mean of 1.1 RFBM per week) crossed over to methylnaltrexone in OLE. During the RCT, 9.7% of placebo-treated patients experienced an RFBM within 4 hours of first dose and 9.0% of all placebo injections resulted in an RFBM within 4 hours compared with 45.9% and 34.5%, respectively, with methylnaltrexone treatment in the OLE. When expressed as percentage of patients experiencing 3 or more RFBMs per week and a 1-RFBM increase over baseline, weekly values ranged from 35% to 41% during placebo treatment; at week 5 of OLE methylnaltrexone, this percentage increased to more than 70% and remained relatively stable throughout the OLE. The most common adverse events during methylnaltrexone treatment were abdominal pain (9.7% vs 1.5% for placebo) and nausea (5.2% vs 6.7%). Conclusions: Findings during placebo treatment further establish the profile of OIC and support that little or no gastrointestinal tolerance develops across time. Findings under open-label conditions established the reproducibility and durability of methylnaltrexone for OIC.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
    No preview · Article · Apr 2014 · Journal of Pain
  • Jaime L Baratta · Kishor Gandhi · Eugene R Viscusi
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    ABSTRACT: Pain management following total knee arthroplasty (TKA) can be challenging. Inadequate pain management following TKA may inhibit rehabilitation, increase morbidity and mortality, decrease patient satisfaction, and lead to chronic persistent postsurgical pain. Traditionally the mainstay of postoperative pain management was opioids; however, the current recommendations to pain management emphasize a multimodal approach and minimizing opioids whenever possible. With careful planning and a multimodal analgesic approach instituted perioperatively, appropriate pain management following TKA can be achieved. Utilizing an extensive review of the literature, this article discusses the analgesic techniques available for the perioperative management of TKA.
    No preview · Article · Mar 2014 · Journal of surgical orthopaedic advances
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    Full-text · Dataset · Jan 2014
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    ABSTRACT: Inadequate control of postoperative pain after orthopedic procedures may trigger complications that increase morbidity. Multimodal analgesia is used to manage pain effectively after surgical procedures and reduce the need for rescue analgesia. Intravenous (IV) acetaminophen (OFIRMEV; Cadence Pharmaceuticals, Inc.), an analgesic that has been studied and used in the multimodal management of acute pain after major orthopedic procedures, combines the safety seen with oral and rectal formulations with a preferred route of administration. Two double-blind, randomized, placebo-controlled clinical trials were conducted (total 130 patients) to determine the efficacy and safety of single-dose IV acetaminophen in patients following total hip arthroplasty. Although both studies were stopped prematurely, overlap in patient populations, study design, and methodologies in the single-dose phase of these studies allowed for analysis of their results to be presented concurrently. Both trials demonstrated IV acetaminophen having greater efficacy than placebo in terms of primary endpoints [pain intensity differences from T0.5 to T3 (P < 0.05 in both studies)]. The use of IV acetaminophen also reduced the need for rescue opioid consumption, with patients receiving IV acetaminophen consuming, on average, less than half the amount of rescue medication as those receiving placebo. IV acetaminophen was effective in treating moderate-to-severe pain after total hip arthroplasty and reduced the need for rescue opioid consumption.
    Full-text · Article · Jan 2014 · American journal of therapeutics
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    Eric S Schwenk · Kishor Gandhi · Eugene R Viscusi
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    ABSTRACT: Interscalene nerve block impairs ipsilateral lung function and is relatively contraindicated for patients with lung impairment. We present a case of an 89-year-old female smoker with prior left lung lower lobectomy and mild to moderate lung disease who presented for right shoulder arthroplasty and insisted on regional anesthesia. The patient received a multimodal perioperative regimen that consisted of a continuous interscalene block, acetaminophen, ketorolac, and opioids. Surgery proceeded uneventfully and postoperative analgesia was excellent. Pulmonary physiology and management of these patients will be discussed. A risk/benefit discussion should occur with patients having impaired lung function before performance of interscalene blocks. In this particular patient with mild to moderate disease, analgesia was well managed through a multimodal approach including a continuous interscalene block, and close monitoring of respiratory status took place throughout the perioperative period, leading to a successful outcome.
    Full-text · Article · Nov 2013
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    ABSTRACT: Optimal postoperative pain management is important to ensure patient comfort and early mobilization. In this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients >=18 years of age who had pain at rest >=5 (0--10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively. Co-primary endpoints included Average Pain Intensity Difference at Rest over Days 1--3 (0- to 10-point NRS) and Average Total Daily Dose of Morphine over Days 1--3. Pain upon movement was evaluated using Average Pain Intensity Difference upon Knee Flexion (0- to 10-point NRS). The primary objective was to demonstrate analgesic superiority for the etoricoxib doses vs. placebo; the secondary objective was to demonstrate that the analgesic effect of the etoricoxib doses was non-inferior to ibuprofen. Adverse experiences (AEs) including opioid-related AEs were evaluated. The least squares (LS) mean (95% CI) differences from placebo for Pain Intensity Difference at Rest over Days 1--3 were -0.54 (-0.95, -0.14); -0.49 (-0.89, -0.08); and -0.45 (-0.85, -0.04) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.05 for etoricoxib vs. placebo). Differences in LS Geometric Mean Ratio morphine use over Days 1--3 from placebo were 0.66 (0.54, 0.82); 0.69 (0.56, 0.85); and 0.66 (0.53, 0.81) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.001 for etoricoxib vs. placebo). Differences in LS Mean Pain Intensity upon Knee Flexion were -0.37 (-0.85, 0.11); -0.46 (-0.94, 0.01); and -0.42 (-0.90, 0.06) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Opioid-related AEs occurred in 41.8%, 34.7%, 36.5%, and 36.3% of patients on placebo, etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Postoperative use of etoricoxib 90 and 120 mg in patients undergoing total knee replacement is both superior to placebo and non-inferior to ibuprofen in reducing pain at rest and also reduces opioid (morphine) consumption.Clinical trial registration: NCT00820027.
    Preview · Article · Oct 2013 · BMC Musculoskeletal Disorders

Publication Stats

2k Citations
306.40 Total Impact Points

Institutions

  • 1999-2015
    • Thomas Jefferson University
      • Department of Anesthesiology
      Filadelfia, Pennsylvania, United States
  • 2013
    • University of Pittsburgh
      • School of Pharmacy
      Pittsburgh, Pennsylvania, United States
  • 2005-2013
    • Thomas Jefferson University Hospitals
      • Department of Anesthesiology
      Philadelphia, Pennsylvania, United States
    • Duke University
      • Department of Anesthesiology
      Durham, North Carolina, United States
  • 2004-2013
    • Jefferson College
      Хиллсборо, Missouri, United States
    • University of Toronto
      Toronto, Ontario, Canada
    • University of Texas Southwestern Medical Center
      • Department of Anesthesiology and Pain Management
      Dallas, Texas, United States
    • Duke University Medical Center
      • Department of Anesthesiology
      Durham, North Carolina, United States
  • 2008
    • Kaiser Permanente
      Oakland, California, United States
  • 2006
    • Loma Linda University
      • Department of Anesthesiology
      Loma Linda, California, United States