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

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          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.

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          Most cited references 21

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          Efficacy of pregabalin in acute postoperative pain: a meta-analysis.

           J ZHANG,  K.-Y. Ho,  Y. WANG (2011)
          Multimodal treatment of postoperative pain using adjuncts such as gabapentin is becoming more common. Pregabalin has anti-hyperalgesic properties similar to gabapentin. In this systematic review, we evaluated randomized, controlled trials (RCTs) for the analgesic efficacy and opioid-sparing effect of pregabalin in acute postoperative pain. A systematic search of Medline (1966-2010), the Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar was performed. We identified 11 valid RCTs that used pregabalin for acute postoperative pain. Postoperative pain intensity was not reduced by pregabalin. Cumulative opioid consumption at 24 h was significantly decreased with pregabalin. At pregabalin doses of <300 mg, there was a reduction of 8.8 mg [weighted mean difference (WMD)]. At pregabalin doses ≥300 mg, cumulative opioid consumption was even lower (WMD, -13.4 mg). Pregabalin reduced opioid-related adverse effects such as vomiting [risk ratio (RR) 0.73; 95% confidence interval (CI) 0.56-0.95]. However, the risk of visual disturbance was greater (RR 3.29; 95% CI 1.95-5.57). Perioperative pregabalin administration reduced opioid consumption and opioid-related adverse effects after surgery.
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            Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial.

            Despite the enormous success of total knee arthroplasty (TKA), chronic neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. We hypothesized that perioperative treatment with pregabalin, a chronic pain medication, would reduce the incidence of postsurgical neuropathic pain. We performed a randomized, placebo-controlled, double-blind trial of pregabalin (300 mg) administered before TKA and for 14 days after TKA (150-50 mg twice daily). Patients were screened for the presence of neuropathic pain at 3 and 6 mo postoperatively using the Leeds Assessment of Neuropathic Symptoms and Signs scale. Secondary outcomes included postsurgical recovery and rehabilitation measures, including knee range of motion, opioid consumption, postoperative pain scores, sleep disturbance, and time to discharge as well as the occurrence of postoperative systemic complications. Of the 240 patients randomly assigned to the 2 treatment groups (120 in each), data for the primary outcome were obtained from 113 pregabalin patients and 115 placebo patients. At both 3 and 6 mo postoperatively, the incidence of neuropathic pain was less frequent in the pregabalin group (0%) compared with the placebo group (8.7% and 5.2% at 3 and 6 mo, respectively; P = 0.001 and P = 0.014). Patients receiving pregabalin also consumed less epidural opioids (P = 0.003), required less oral opioid pain medication while hospitalized (P = 0.005), and had greater active flexion over the first 30 postoperative days (P = 0.013). There were no differences in the actual recorded duration of hospitalization between the 2 groups, although time to achieve hospital discharge criteria was longer for placebo patients, 69.0 +/- 16.0 h (mean +/- SD), than that of pregabalin patients, 60.2 +/- 15.8 h (P = 0.001). Sedation (P = 0.005) and confusion (P = 0.013) were more frequent on the day of surgery and postoperative day 1 in patients receiving pregabalin. Perioperative pregabalin administration reduces the incidence of chronic neuropathic pain after TKA, with less opioid consumption and better range of motion during the first 30 days of rehabilitation. However, in the doses tested, it is associated with a higher risk of early postoperative sedation and confusion.
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              Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy.

              Postoperative pain is the dominating complaint and the primary reason for prolonged convalescence after laparoscopic cholecystectomy. We have evaluated the efficacy of a single preoperative dose of pregabalin for attenuating postoperative pain and fentanyl consumption after laparoscopic cholecystectomy. Sixty adults (16-60 yr), ASA physical status I and II, of either sex undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized placebo controlled, double-blind study. Subjects were divided into two groups of 30 each to receive either a matching placebo or pregabalin 150 mg, administered orally 1 h before surgery. Postoperative pain (static and dynamic) was assessed by a 100 mm visual analogue scale, where 0, no pain; 100, worst imaginable pain. Subjects received patient-controlled i.v. fentanyl analgesia during the postoperative period. Results were analysed by Student's t-test, chi(2) test, Mann-Whitney U-test, and Fisher's exact test. Postoperative pain (static and dynamic) and postoperative patient-controlled fentanyl consumption were reduced in the pregabalin group compared with the placebo group (P<0.05). Side-effects were similar in both groups. A single preoperative oral dose of pregabalin 150 mg is an effective method for reducing postoperative pain and fentanyl consumption in patients undergoing laparoscopic cholecystectomy.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2015
                23 December 2014
                : 8
                : 9-20
                Affiliations
                [1 ]Lotus Clinical Research, Pasadena, CA, USA
                [2 ]Division of Acute Interventional Perioperative Pain, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
                [3 ]Department of Orthopedic Surgery, Baylor College of Medicine, Houston, TX, USA
                [4 ]Arizona Research Center, Phoenix, AZ, USA
                [5 ]Pfizer Inc., New York, NY, USA
                [6 ]Pfizer Inc., New London, CT, USA
                Author notes
                Correspondence: Neil K Singla, Huntington Hospital, 100 W California Boulevard, Pasadena, CA 91105, USA, Tel +1 626 397 3507, Fax +1 626 628 3422, Email neil@ 123456lotuscr.com
                Article
                jpr-8-009
                10.2147/JPR.S67841
                4278776
                © 2015 Singla et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

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