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      The analgesic efficiency of pregabalin for the treatment of postoperative pain in total hip arthroplasty : A randomized controlled study protocol

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          Abstract

          Background:

          Only few studies have yet investigated whether perioperative administration of pregabalin can reduce the incidence of postoperative chronic neuropathic pain after total hip arthroplasty (THA). This prospective, randomized study compared placebo with pregabalin in the hope that a lower pregabalin dose would improve analgesia without increasing side-effects after THA.

          Methods:

          This study was a prospective randomized blinded study, with a parallel design and an allocation ratio of 1:1 for the treatment groups. The study was approved by the Institutional Review Board in Weifang People's Hospital and written informed consent was obtained from all subjects before enrolment. A total of 120 patients who meet inclusion criteria are randomized to either pregabalin or placebo group. The primary objective of the study was visual analog scale score. As secondary outcomes, opioid consumption measurement, Harris Hip Score, hip range of motion, patient satisfaction, and complications were made at different time points throughout the study for comparison.

          Results:

          The null hypothesis of this study was that pregabalin would reduce pain after THA.

          Trial registration:

          This study protocol was registered in Research Registry (researchregistry5669).

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          Most cited references20

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          Pharmacology and mechanism of action of pregabalin: the calcium channel alpha2-delta (alpha2-delta) subunit as a target for antiepileptic drug discovery.

          Pregabalin (Lyrica) is a new antiepileptic drug that is active in animal seizure models. Pregabalin is approved in US and Europe for adjunctive therapy of partial seizures in adults, and also has been approved for the treatment of pain from diabetic neuropathy or post-herpetic neuralgia in adults. Recently, it has been approved for treatment of anxiety disorders in Europe. Pregabalin is structurally related to the antiepileptic drug gabapentin and the site of action of both drugs is similar, the alpha2-delta (alpha2-delta) protein, an auxiliary subunit of voltage-gated calcium channels. Pregabalin subtly reduces the synaptic release of several neurotransmitters, apparently by binding to alpha2-delta subunits, and possibly accounting for its actions in vivo to reduce neuronal excitability and seizures. Several studies indicate that the pharmacology of pregabalin requires binding to alpha2-delta subunits, including structure-activity analyses of compounds binding to alpha2-delta subunits and pharmacology in mice deficient in binding at the alpha2-delta Type 1 protein. The preclinical findings to date are consistent with a mechanism that may entail reduction of abnormal neuronal excitability through reduced neurotransmitter release. This review addresses the preclinical pharmacology of pregabalin, and also the biology of the high affinity binding site, and presumed site of action.
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            Pregabalin: its pharmacology and use in pain management.

            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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              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
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                02 July 2020
                02 July 2020
                : 99
                : 27
                : e21071
                Affiliations
                Department of Anesthesiology, Weifang People's Hospital, Shandong 261000, China.
                Author notes
                []Correspondence: Guimin Dong, Department of Anesthesiology, Weifang People's Hospital, Shandong 261000, China (e-mail: guimin1990@ 123456163.com ).
                Author information
                http://orcid.org/0000-0001-6910-3268
                Article
                MD-D-20-05294 21071
                10.1097/MD.0000000000021071
                7337400
                32629738
                f3a14875-b6f1-4803-950d-d325b2794373
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 2 June 2020
                : 3 June 2020
                Funding
                Funded by: China National Funds for Distinguished Young Scientists
                Award ID: C100117
                Award Recipient : Not Applicable
                Categories
                7100
                Research Article
                Study Protocol Clinical Trial
                Custom metadata
                TRUE

                pain control,pregabalin,randomized controlled trial,study protocol,total hip arthroplasty

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