The effect of intraperitoneal ropivacaine on postoperative pain and recovery after diagnostic laparoscopy and hysterosocopy: A Randomised Double Blind Placebo Controlled Trial

Study Objective: To determine the effect of intraperitoneal ropivacaine on postoperative pain, nausea and recovery following diagnostic laparoscopy and hysteroscopy, women followed up for first eight hours after discharge. Design: Randomised Placebo Controlled Double Blinded Trial (Canadian Task Force Classification I) Setting: Single day case surgery hospital in Australia Patients: Well women aged 18 – 50 years, undergoing day case hysteroscopy and diagnostic laparoscopy for gynaecological indications. Interventions: 100mg intraperietoneal ropivacaine (intervention) or 100mg normal saline (placebo control) inserted intraperitoneally at the end of the procedure Measurements and Main Results: 59 patients included for analysis. 31 patients randomized to Ropivacaine and 28 patients to Control. Time to discharge was 20 minutes faster in patients randomized to Ropivacaine, however, this finding did not reach significance. Overall pain scores and nausea scores also showed no significant differences. There was no significant difference in opioid requirement between those receiving Ropivacaine versus controls. Conclusion: Intraperitoneal ropivacaine did not result in any significant pain, nausea or recovery time benefits when compared with control, in this randomized trial for women undergoing day case hysteroscopy diagnostic laparoscopy. No adverse effects of ropivacaine were identified. Trial was prospectively registered with the Australian Clinical Trials Registry trial number ACTRN12609000128291, date registered 23/02/2009

研究目的：探讨腹腔内罗哌卡因对诊断性腹腔镜联合宫腔镜手术患者术后疼痛、恶心及术后恢复的影响，研究随访对象为出院后前8小时内的女性患者。
试验设计：随机安慰剂对照双盲试验（加拿大工作组分类I级，Canadian Task Force Classification I）
试验场景：澳大利亚单日门诊手术医院
研究对象：年龄18~50岁的健康女性，因妇科适应证接受门诊宫腔镜联合诊断性腹腔镜手术
干预措施：手术结束时于腹腔内给予100mg罗哌卡因（干预组）或100mg生理盐水（安慰剂对照组）
测量指标与主要结果：共计59例患者纳入最终分析，其中31例被随机分配至罗哌卡因组，28例分配至对照组。罗哌卡因组患者的出院时间较对照组提前20分钟，但该差异未达到统计学显著性。两组患者的总体疼痛评分、恶心评分以及阿片类药物使用需求量均无显著差异。
结论：在这项针对接受门诊宫腔镜联合诊断性腹腔镜手术女性患者的随机对照试验中，与对照组相比，腹腔内给予罗哌卡因并未在缓解术后疼痛、减轻恶心或缩短恢复时长方面产生显著获益，且未观察到罗哌卡因相关的不良反应。
试验注册信息：本试验已在澳大利亚临床试验注册库完成前瞻性注册，注册编号为ACTRN12609000128291，注册日期为2009年2月23日。