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      Pregabalin to improve postoperative recovery in bariatric surgery: a parallel, randomized, double-blinded, placebo-controlled study

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          Abstract

          Purpose

          Obesity has been considered as a major public health problem in developed countries for which bariatric surgery has become an important treatment strategy. Postoperative pain, however, is a frequent problem in postoperative management. Pregabalin blocks the development of hyperalgesia and central pain sensitization. The objective of this randomized, placebo-controlled, double-blinded trial was to evaluate the effect of a single dose of preoperative pregabalin vs placebo on the quality of postoperative recovery in patients undergoing bariatric surgery.

          Patients and methods

          A total of 70 patients undergoing abdominal gastroplasty were randomly assigned to receive oral pregabalin (75 mg) or an identical placebo 1 hour before surgery. The primary outcome was Quality of Recovery-40 (QoR-40) score at 24 hours. Secondary outcomes included opioid consumption and postoperative pain scores. P<0.05 was considered to indicate statistical significance.

          Results

          In all, 60 of the 70 patients completed the study. The mean (SD) global recovery scores (QoR-40) 24 hours after surgery in the pregabalin and control groups were 183.7 (9) and 182.1 (12), respectively (mean difference=1.6, 95% CI –7.36 to 4.2, P=0.59). There was no significant difference in the total opioid consumption in the 24 hours following surgery between the two groups (pregabalin vs control=0.47×0.2; mean difference=0.26, 95% CI −0.24 to 0.77, P=0.3). There were no significant differences in nausea, vomiting, or time to postanesthesia care unit discharge between the two groups.

          Conclusion

          In patients who underwent bariatric surgery, a single preoperative dose of pregabalin (75 mg) did not improve pain relief, quality of postoperative recovery, or reduction in opioid consumption.

          Clinical trial registration

          http://www.ensaiosclinicos.gov.br (identifier: RBR-2g89x8).

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          Most cited references 28

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          Validity and reliability of a postoperative quality of recovery score: the QoR-40.

          Quality of recovery after anaesthesia is an important measure of the early postoperative health status of patients. We attempted to develop a valid, reliable and responsive measure of quality of recovery after anaesthesia and surgery. We studied 160 patients and asked them to rate postoperative recovery using three methods: a 100-mm visual analogue scale (VAS), a nine-item questionnaire and a 50-item questionnaire; the questionnaires were repeated later on the same day. From these results, we developed a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200). We found good convergent validity between QoR-40 and VAS (r = 0.68, P < 0.001). Construct validity was supported by a negative correlation with duration of hospital stay (rho = -0.24, P < 0.001) and a lower mean QoR-40 score in women (162 (SD 26)) compared with men (173 (17)) (P = 0.002). There was also good test-retest reliability (intra-class ri = 0.92, P < 0.001), internal consistency (Cronbach's alpha = 0.93, P < 0.001) and split-half coefficient (alpha = 0.83, P < 0.001). The standardized response mean, a measure of responsiveness, was 0.65. The QoR-40 was completed in less than 6.3 (4.9) min. We believe that the QoR-40 is a good objective measure of quality of recovery after anaesthesia and surgery. It would be a useful end-point in perioperative clinical studies.
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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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              Pregabalin: its pharmacology and use in pain management.

               Noor M Gajraj (2007)
              Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid. It is an alpha2-delta (alpha2-delta) ligand that has analgesic, anticonvulsant, anxiolytic, and sleep-modulating activities. Pregabalin binds potently to the alpha2-delta subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters, including glutamate, noradrenaline, serotonin, dopamine, and substance P. In this review, I will discuss the pharmacology of pregabalin and available efficacy studies in pain management. This review will focus on the advances in pregabalin pharmacology since my previous review in 2005.
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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
                2018
                17 October 2018
                : 11
                : 2407-2415
                Affiliations
                [1 ]Department of Anesthesiology, São Paulo State University (UNESP), São Paulo, Brazil, celoufba@ 123456yahoo.com.br
                [2 ]Department of Anesthesiology at Federal University of Bahia, Bahia, Brazil
                [3 ]Department of Anesthesiology, Santo Antonio Hospital, Salvador, Bahia, Brazil
                [4 ]Department of Anesthesia, Bahia University of Medicine and Public Health, Bahia, Brazil
                [5 ]Department of Anesthesiology, Hospital Sao Rafael, Salvador, Bahia, Brazil
                [6 ]Department of Surgery, Hospital Tereza de Lisieux, Salvador, Bahia, Brazil
                [7 ]Department of Anaesthesiology, São Paulo State University (UNESP), Botucatu, Brazil
                Author notes
                Correspondence: Marcelo J Martins, Department of Anesthesiology, University of Medicine of Botucatu, Rubiao Jr. District, mailbox 530, Botucatu 18618-970, Brazil, Tel +55 71 99139 3736, Email celoufba@ 123456yahoo.com.br
                Article
                jpr-11-2407
                10.2147/JPR.S176468
                6200430
                © 2018 Martins et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Clinical Trial Report

                Anesthesiology & Pain management

                gastroplasty, hyperalgesia, opioid

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