普瑞巴林对腹腔镜子宫切除术患者疼痛的剂量效应：一项随机、双盲、安慰剂对照临床试验
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普瑞巴林对腹腔镜子宫切除术患者疼痛的剂量效应：一项随机、双盲、安慰剂对照临床试验
贵州医科大学 麻醉与心脏电生理课题组
翻译：刘云琴 编辑：张中伟 审校：曹莹
本研究旨在探讨不同浓度（75、150和300 mg）的普瑞巴林用于腹腔镜子宫切除术后疼痛管理的超前镇痛效果。设计：前瞻性、随机、安慰剂对照、双盲研究。
伊朗德黑兰阿拉什医院妇产科中心，2013年10月至2014年11月.
总共96名身体状况良好，ASA分级为I级和II级的妇女接受了选择性腹腔镜子宫切除术。然后将患者随机分为四组，其中第1-3组（治疗组；n=20）在术前一晚、术前30分钟和术后6小时分别口服浓度为75 mg、150 mg和300 mg的普瑞巴林，第4组（对照组；n=22）在同一方案中接受相同剂量的安慰剂.
测量方法
评估术后24h静息疼痛和运动疼痛的VAS评分作为主要结果。药物相关的副作用也被评估为次要结果。采用ramsay镇静量表评定嗜睡程度，采用数字评分法评定恶心呕吐程度。数据是用spss软件分析的。
主要结果
与安慰剂相比，不同浓度的普瑞巴林超前镇痛具有更好的镇痛效果。事后测试表明，四组之间存在显著差异，表明浓度增加时，疼痛评分作为时间的独立变量降低。与其他组相比，普瑞巴林的最高浓度（300毫克）显示出更高的镇静评分。
我们的数据表明，预先给予75、150和300mg普瑞巴林在减少腹腔镜子宫切除术后疼痛方面起着重要作用。不同浓度和副作用的比较表明，口服150 mg普瑞巴林是腹腔镜子宫切除术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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