Dataset Information

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models.

ABSTRACT: PURPOSE:To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d) as an adjunctive therapy for the treatment of postoperative pain. PATIENTS AND METHODS:This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study): elective inguinal hernia repair (post-IHR); elective total knee arthroplasty (post-TKA); or total abdominal hysterectomy (posthysterectomy). The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity. RESULTS:In total, 425 (post-IHR), 307 (post-TKA), and 501 (posthysterectomy) patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was -0.7 (95% confidence interval [CI] =-1.4, -0.1; Hochberg adjusted P=0.067) post-IHR; -0.34 (95% CI =-1.07, 0.39; P=0.362) post-TKA; and -0.2 (95% CI =-0.66, 0.31; P=0.471) posthysterectomy. CONCLUSION:There were no significant differences between pregabalin and placebo with respect to the primary pain intensity measure in each of the three clinical trials. These studies encompass a large dataset (1,233 patients in total), and their results should be considered when assessing pregabalin's effectiveness in postoperative pain. Further studies are required to determine the potential pain-reducing benefit of pregabalin in the postoperative setting.

SUBMITTER: Singla NK

PROVIDER: S-EPMC4278776 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models.

Singla Neil K NK Chelly Jacques E JE Lionberger David R DR Gimbel Joseph J Sanin Luis L Sporn Jonathan J Yang Ruoyong R Cheung Raymond R Knapp Lloyd L Parsons Bruce B

Journal of pain research 20141223

<h4>Purpose</h4>To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d) as an adjunctive therapy for the treatment of postoperative pain.<h4>Patients and methods</h4>This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study): elective inguinal hernia repair (post-IHR); elect ...[more]

PMID: 25565885

Similar Datasets

Project description:The efficacy of pregabalin in acute postsurgical pain has been demonstrated in numerous studies; however, the analgesic efficacy and adverse effects of using pregabalin in various surgical procedures remain uncertain. We aim to assess the postsurgical analgesic efficacy and adverse events after pregabalin administration under different surgical categories using a systematic review and meta-analysis of randomized controlled trials.A search of the literature was performed between August 2014 to April 2015, using PubMed, Ovid via EMBASE, Google Scholar, and ClinicalTrials.gov with no limitation on publication year or language. Studies considered for inclusion were randomized controlled trials, reporting on relevant outcomes (2-, 24-hour pain scores, or 24 hour morphine-equivalent consumption) with treatment with perioperative pregabalin.Seventy-four studies were included. Pregabalin reduced pain scores at 2 hours in all categories: cardiothoracic (Hedge's g and 95%CI, -0.442 [-0.752 to -0.132], P?=?0.005), ENT (Hedge g and 95%CI, -0.684 [-1.051 to -0.316], P?<?0.0001), gynecologic (Hedge g, 95%CI, -0.792 [-1.235 to -0.350], P?<?0.0001), laparoscopic cholecystectomy (Hedge g, 95%CI, -0.600 [-0.989 to -0.210], P?=?0.003), orthopedic (Hedge g, 95%CI, -0.507 [-0.812 to -0.202], P?=?0.001), spine (Hedge g, 95%CI, -0.972 [-1.537 to -0.407], P?=?0.001), and miscellaneous procedures (Hedge g, 95%CI, -1.976 [-2.654 to -1.297], P?<?0.0001). Pregabalin reduced 24-hour morphine consumption in gynecologic (Hedge g, 95%CI, -1.085 [-1.582 to -0.441], P?=?0.001), laparoscopic cholecystectomy (Hedge g, 95%CI, -0.886 [-1.652 to -0.120], P?=?0.023), orthopedic (Hedge g, 95%CI, -0.720 [-1.118 to -0.323], P?<?0.0001), spine (Hedge g, 95%CI, -1.016 [-1.732 to -0.300], P?=?0.005), and miscellaneous procedures (Hedge g, 95%CI, -1.329 [-2.286 to -0.372], P?=?0.006). Pregabalin resulted in significant sedation in all surgical categories except ENT, laparoscopic cholecystectomy, and gynecologic procedures. Postoperative nausea and vomiting was only significant after pregabalin in miscellaneous procedures.Analgesic effects and incidence of adverse effects of using pregabalin are not equal in different surgical categories.

Project description:BackgroundPregabalin is approved by the US Food and Drug Administration for the treatment of fibromyalgia (FM), diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and neuropathic pain due to spinal cord injury (SCI). Approval was based on clinical trial data demonstrating statistically significant differences in pain scores versus placebo. However, statistically significant pain relief may not always equate to clinically meaningful pain relief. To further characterize the clinical benefit of pregabalin, this analysis examined shifts in pain severity categories in patients with FM, DPN/PHN (pooled in this analysis), and SCI treated with pregabalin.MethodsData were pooled from 23 placebo-controlled trials in patients with FM (1,623 treated with pregabalin, 937 placebo), DPN/PHN (2,867 pregabalin, 1,532 placebo), or SCI (181 pregabalin, 175 placebo). Pain scores were assessed on an 11-point numeric rating scale and categorized as mild (0 to <4), moderate (4 to <7), or severe (7 to 10). Only patients with mean score ≥4 at baseline were randomized to treatment. The percentage of patients shifting pain category from baseline to endpoint for pregabalin and placebo was analyzed using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure.ResultsA higher proportion of patients shifted to a less severe pain category at endpoint with pregabalin compared with placebo. With flexible-dose pregabalin, the percentage of patients improving from: severe to mild (pregabalin versus placebo) was 15.8 versus 13.4 in FM patients, 36.0 versus 16.6 in DPN/PHN patients, 14.3 versus 7.7 in SCI patients; severe to moderate was 28.7 versus 28.2 in FM patients, 32.5 versus 28.2 in DPN/PHN patients, 35.7 versus 28.2 in SCI patients; and moderate to mild was 38.3 versus 26.4 in FM patients, 59.5 versus 41.4 in DPN/PHN patients, 38.6 versus 27.2 in SCI patients.ConclusionCompared with placebo, pregabalin is more often associated with clinically meaningful improvements in pain category in patients with FM, DPN, PHN, or SCI.

Project description:BackgroundWe performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of pregabalin for pain management following spine surgery.MethodsIn September 2016, a systematic computer-based search was conducted in PubMed, EMBASE, Web of Science, and Cochrane Database of Systematic Reviews. RCTs of patients prepared for spine surgery that compared pregabalin with placebo were retrieved. The primary endpoint was the VAS score with rest or mobilization at 12 hours, 24 hours, and 48 hours and cumulative morphine consumption at 24 hours and 48 hours. The secondary outcomes were complications of nausea, sedation, dizziness, headache, and visual disturbances. After testing for publication bias and heterogeneity between studies, data were aggregated for random-effects models when necessary.ResultsTen clinical studies with 535 patients (pregabalin group = 294, control group = 241) were included in the meta-analysis. Pregabalin was associated with reduced pain scores at 12 hours, 24 hours, and 48 hours, corresponding to a reduction of 1.91 points (95% CI, -4.07 to 0.24 point) at 12 hours, 2.66 points (95% CI, -4.51 to -0.81 point) at 24 hours, and 4.33 points (95% confidence interval, -6.38 to -2.99 point) at 48 hours on a 100-point numeric rating scale. There was no significant difference between VAS scores with mobilization at 12 hours, 24 hours, or 48 hours. Similarly, pregabalin was associated with a reduction in cumulative morphine consumption at 24 hours (-7.07, 95% CI -9.84, -4.30) and 48 hours (-6.52, 95% CI -7.78, -5.25, P = 0.000). Furthermore, pregabalin can reduce the occurrence of nausea (RR 0.57, 95% CI 0.41, 0.79, P = 0.001, number needed to treat = 8.4). There were no significant differences in the occurrence of sedation, dizziness, headache, or visual disturbances.ConclusionsPreoperative use of pregabalin was efficacious in reduction of postoperative pain, total morphine consumption, and the occurrence of nausea following spine surgery. Because the sample size and the number of included studies were limited, a multicenter RCT is needed to identify the effects and optimal dose of pregabalin for reducing acute pain after spine surgery.

Project description:BackgroundWhether the preoperative administration of pregabalin plays a beneficial role in controlling acute pain after hysterectomy is unknown. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to determine the efficacy and safety of the preoperative use of pregabalin to treat acute postoperative pain following hysterectomy.MethodsIn April 2017, a systematic computer-based search was conducted in the PubMed, EMBASE, Web of Science, Cochrane Library, and Google databases. RCTs comparing pregabalin with placebo in patients undergoing hysterectomy were retrieved. The primary endpoint was the visual analog scale (VAS) score with rest or mobilization at 2?h, 4 and 24?hours and cumulative morphine consumption at 2, 4, 24, and 48?hours. The secondary outcomes were complications of nausea, vomiting, sedation, and dizziness. After tests for publication bias and heterogeneity among studies were performed, the data were aggregated for random-effects models when necessary.ResultsTen clinical studies with 1207 patients (pregabalin?=?760, control?=?447) were finally included in this meta-analysis. Preoperative administration of pregabalin was associated with a significant reduction of VAS with rest or mobilization at 2, 4, and 24?hours after hysterectomy. Further, the preoperative administration of pregabalin was associated with a reduction in total morphine consumption at 2, 4, 24, and 48?hours after hysterectomy. The occurrence of morphine-related complications (nausea and vomiting) was also reduced in the pregabalin group. However, the preoperative administration of pregabalin was associated with an increase in the occurrence of dizziness. There was no significant difference in the occurrence of sedation.ConclusionsThe preoperative use of pregabalin reduced postoperative pain, total morphine consumption, and morphine-related complications following hysterectomy. The doses of pregabalin were different, and large heterogeneity was the limitation of the current meta-analysis. Further studies should determine the optimal dose for controlling acute pain after hysterectomy.

Dataset Information

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models.

Publications

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets