普瑞巴林对腹腔镜子宫切除术患者疼痛的剂量范围效应:一项随机、双盲、安慰剂对照的临床试验。

Dose ranging effects of pregabalin on pain in patients undergoing laparoscopic hysterectomy: A randomized, double blinded, placebo controlled, clinical trial.

机构信息

Department of Obstetrics and Gynecology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.

Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Clin Anesth. 2017 May;38:13-17. doi: 10.1016/j.jclinane.2017.01.015. Epub 2017 Jan 13.

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 groups 1-3 (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.

摘要

目的

本研究旨在探讨不同浓度(75、150 和 300mg)的普瑞巴林超前镇痛对腹腔镜子宫切除术后疼痛管理的效果。

设计

前瞻性、随机、安慰剂对照、双盲研究。

地点

伊朗德黑兰 Arash 医院妇产科中心,2013 年 10 月至 2014 年 11 月。

患者

96 例美国麻醉医师协会(ASA)身体状况 I 和 II 级的女性患者接受择期腹腔镜子宫切除术。患者随后被随机分为四组,其中 1-3 组(治疗组;n=20)分别在手术前一晚、手术前 30 分钟和手术后 6 小时口服不同浓度的普瑞巴林 75mg、150mg 和 300mg,而 4 组(对照组;n=22)在相同方案下接受匹配剂量的安慰剂。

测量

评估术后 24 小时内静息和运动时的视觉模拟评分(VAS)作为主要结果。还评估了与药物相关的副作用作为次要结果。使用 Ramsay 镇静评分评估嗜睡,使用数字评分评估恶心和呕吐。数据使用 SPSS 进行分析。

主要结果

不同浓度的普瑞巴林超前镇痛与安慰剂相比能提供更好的疼痛缓解。事后检验表明,四组之间存在显著差异,表明随着浓度的增加,疼痛评分作为时间的独立变量而降低。普瑞巴林的最高浓度(300mg)与其他组相比显示出更高的镇静评分。

结论

我们的数据表明,75、150 和 300mg 普瑞巴林的超前给药在腹腔镜子宫切除术后减轻术后疼痛方面发挥重要作用。不同浓度和副作用的比较表明,口服 150mg 普瑞巴林是腹腔镜子宫切除术后管理术后疼痛的一种有效且安全的方法。

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