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：明确腹腔内罗哌卡因（ropivacaine）对诊断性腹腔镜联合宫腔镜手术患者术后疼痛、恶心及康复状态的影响，受试者于出院后前8小时内接受随访。
研究设计：随机安慰剂对照双盲试验（加拿大任务组分类I级）
研究场景：澳大利亚单一日间手术医院
受试者：年龄18~50岁、因妇科指征接受日间宫腔镜联合诊断性腹腔镜手术的健康女性
干预方案：手术结束时经腹腔给予100mg罗哌卡因（干预组）或100mg生理盐水（安慰剂对照组）
测量指标与主要研究结果：共纳入59例患者进行分析，其中罗哌卡因组31例，对照组28例。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；总体疼痛评分与恶心评分亦无显著差异。罗哌卡因组与对照组的阿片类药物使用需求量无显著差异。
结论：在这项针对接受日间宫腔镜联合诊断性腹腔镜手术女性的随机对照试验中，与对照组相比，腹腔内给予罗哌卡因并未在疼痛、恶心或康复时间方面带来显著获益，且未观察到罗哌卡因相关的不良反应。
本试验已前瞻性在澳大利亚临床试验注册库（Australian Clinical Trials Registry）完成注册，注册编号为ACTRN12609000128291，注册日期为2009年2月23日