手术前口服普瑞巴林用于缓解妇科小手术术后疼痛的随机安慰剂对照实验  

作　　者：Michael J. Paech Raymond Goy Sebastian Chua Karen Scott Tracey Christmas Dorota A. Doherty 彭宇(译) 蒋宗滨(校) 

机构地区：[1]Pharmacology and Anaesthesiology Unit, School of Medicine and Pharmacology, The University of Western Australia [2]Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women [3]Research Design and Biostatistics Unit, Women and Infants Research Foundation, Perth, Western Australia, Australia [4]不详

出　　处：《麻醉与镇痛》2008年第5期49-53,共5页Anesthesia & Analgesia

摘　　要：背景尽管普瑞巴林能有效治疗神经病理性疼痛，但是否能有效控制手术后疼痛仍证据不足。我们的研究目的是调查分析普瑞巴林对发生急性内脏痛的日间手术患者的镇痛效果。假设是普瑞巴林和安慰剂的镇痛效果差异无显著性。方法对90例行子宫手术的妇科小手术妇女进行随机双盲平行安慰剂对照试验。患者在手术前约1小时口服普瑞巴林100mg（PG组）或安慰剂（C组）。观察结果是患者在恢复室和手术后24小时的疼痛评分。结果两组患者在恢复室的疼痛评分（PG组的中位数、四分位间距分别为16和0～36；C组中位数、四分位间距分别为10和6．5—36，P=0．80）和此后所经历的疼痛差异无显著性；两组患者恢复室内芬太尼用量（PG组为42％，C组为27％，P=0．12）或手术后24小时恢复质量（PG组和c组的中位数、四分位间距分别为17、17—18小时和18、16．5～18，P=O．75）差异也无显著性。出院后轻度头晕、视觉障碍和行走困难的发生率普瑞巴林组明显高于安慰剂组。结论只进行单纯子宫操作的妇科小手术患者，手术前服用单次剂量普瑞巴林100mg不能减轻其手术后急性疼痛以及改善其恢复质量。BACKGROUND： Although pregabalin shows efficacy against neuropathic pain, very limited evidence supports postoperative analgesic efficacy. Our study objective was to investigate analgesic efficacy in an ambulatory day surgical population experiencing acute visceral pain. The null hypothesis was that there was no significant difference in pain relief between pregabalin and placebo. METHODS： A randomized, double-blind, parallel-group, placebo-controlled trial was performed in 90 women having minor gynecological surgery involving the uterus. Patients received either oral pregabalin 100 mg （ Group PG） or placebo （ Group C） approximately 1 h before surgery. The primary outcome was pain score in the recovery unit and patients were followed for 24 h. RESULTS： There was no significant difference between groups for pain experienced in the recovery room （median, interquartile range 16, 0 -36 vs 10, 6.5 -36 for Groups PG and C, respectively, P = 0. 80） or thereafter; nor for recovery room fentanyl requirement （42% Group PG versus 27% Group C, P = 0. 12） or the quality of recovery at 24 h postoperatively （median, interquartile range score 17, 17 - 18 Group PG versus 18, 16.5 - 18 Group C, P = 0. 75 ）. The incidence of posthospital discharge light-headedness, visual disturbance, and difficulty with walking was significantly higher in the pregabalin group. CONCLUSIONS： A single preoperative dose of 100 mg pregabalin does not reduce acute pain or improve recovery after minor surgery involving only the uterus.

关 键 词：手术后疼痛 随机安慰剂 妇科小手术 普瑞巴林 术前口服 对照实验 神经病理性疼痛 缓解 

分 类 号：R619[医药卫生—外科学] R774.5[医药卫生—临床医学]