普瑞巴林對腹腔鏡子宮切除術患者疼痛的劑量效應：一項隨機、雙盲、安慰劑對照臨床試驗
貴州醫(yī)科大學 麻醉與心臟電生理課題組
翻譯：劉云琴 編輯：張中偉 審校：曹瑩
本研究旨在探討不同濃度（75、150和300 mg）的普瑞巴林用于腹腔鏡子宮切除術后疼痛管理的超前鎮(zhèn)痛效果。設計：前瞻性、隨機、安慰劑對照、雙盲研究。
伊朗德黑蘭阿拉什醫(yī)院婦產(chǎn)科中心，2013年10月至2014年11月.
總共96名身體狀況良好，ASA分級為I級和II級的婦女接受了選擇性腹腔鏡子宮切除術。然后將患者隨機分為四組，其中第1-3組（治療組；n=20）在術前一晚、術前30分鐘和術后6小時分別口服濃度為75 mg、150 mg和300 mg的普瑞巴林，第4組（對照組；n=22）在同一方案中接受相同劑量的安慰劑.
測量方法
評估術后24h靜息疼痛和運動疼痛的VAS評分作為主要結果。藥物相關的副作用也被評估為次要結果。采用ramsay鎮(zhèn)靜量表評定嗜睡程度，采用數(shù)字評分法評定惡心嘔吐程度。數(shù)據(jù)是用spss軟件分析的。
主要結果
與安慰劑相比，不同濃度的普瑞巴林超前鎮(zhèn)痛具有更好的鎮(zhèn)痛效果。事后測試表明，四組之間存在顯著差異，表明濃度增加時，疼痛評分作為時間的獨立變量降低。與其他組相比，普瑞巴林的最高濃度（300毫克）顯示出更高的鎮(zhèn)靜評分。
我們的數(shù)據(jù)表明，預先給予75、150和300mg普瑞巴林在減少腹腔鏡子宮切除術后疼痛方面起著重要作用。不同濃度和副作用的比較表明，口服150 mg普瑞巴林是腹腔鏡子宮切除術后疼痛管理的有效和安全的方法。
Asgari Zahra,Rouholamin Safoura,Nataj Masoomeh et al. Dose ranging effects of pregabalin on pain in patients undergoing laparoscopic hysterectomy: A randomized, double blinded, placebo controlled, clinical trial.[J] .J Clin Anesth, 2017, 38: 13-17.
Dose ranging effects of pregabalin on pain in patients undergoing laparoscopic hysterectomy: A randomized, double blinded, placebo controlled, clinical trial
Abstract
OBJECTIVE:The study aimed to investigate the preemptive analgesia efficacy of different concentrations (75, 150 and 300mg) of preemptive pregabalin for the postoperative pain management after laparoscopic hysterectomy.
DESIGN:Prospective, randomized, placebo-controlled, double-blind study.
SETTING:The Gynecology and Obstetrics Center of Arash Hospital, Tehran, Iran, from October 2013 to November 2014.
PATIENTS:A total of 96 women with American Association of Anesthesiologist (ASA) physical status I and II underwent elective laparoscopic hysterectomy surgery. Patients were then randomly assigned to four groups, of which groups1-3 (treatment groups; n=20) received orally pregabalin concentrations of 75mg, 150mg, and 300mg, respectively, for a night before surgery, 30min before surgery and 6h after surgery, whereas group 4 (control group; n=22) received a matching dosage of placebo at the same scheme.
MEASUREMENTS:Visual Analog Scale (VAS) scores for postoperative pain at rest and on movement at first 24h after surgery were evaluated as primary outcome. Drug-related side effects were also evaluated as a secondary outcome. Somnolence was evaluated using Ramsay Sedation Scale, while nausea and vomiting were assessed using numeric scores. The data were analyzed using SPSS.
MAIN RESULTS:Preemptive pregabalin in different concentrations provided better pain relief as compared with placebo. Post-hoc test indicated that there was a significant difference among four groups, indicating where the concentration was increased, the pain score decreased as an independent variable of time. The highest concentration of pregabalin (300mg) revealed higher sedation scores as compared with other groups.
CONCLUSION:Our data demonstrated preemptive administration of 75, 150, and 300mg pregabalin play an important role in reducing postoperative pain after laparoscopic hysterectomy. Comparison of different concentrations and side effects indicates oral administration of 150mg pregabalin is an effective and safe method for postoperative pain management after laparoscopic hysterectomy.
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