BACKGROUND In a previous phase II trial, intraperitoneal local anaesthetics shortened the time interval between surgery and adjuvant chemotherapy, an endpoint associated with improved survival in advanced ovarian cancer. Our objective was to test this in a phase III trial. METHODS A double-blind, phase III parallel superiority trial was conducted at two university hospitals in Sweden, within a public and centralised healthcare system. Women >18 yr with advanced ovarian cancer scheduled for cytoreductive surgery, an ASA physical status of 1-3 with no speech/language issues, were eligible. Participants were randomly assigned using a central computerised system to receive either ropivacaine 0.2% or saline 0.9% (placebo) intraperitoneally during and after surgery. The primary endpoint was time to return to intended oncologic therapy (RIOT), analysed using t-test and linear regression adjusted for centre. RESULTS Of the 225 women randomised between August 2020 and December 2023 (ropivacaine n=113; placebo n=112), 175 were included in the modified intention-to-treat analysis (ropivacaine n=86; placebo n=89). Median age: ropivacaine group 64 yr (56-73 yr), placebo group: 66 yr (57-74 yr). The mean RIOT in the ropivacaine group was 26.5 days vs 25.8 days in the placebo group, with a mean difference of 0.7 days (-2.2 to 3.4 days; P=0.65). Per-protocol analysis of 166 women yielded similar results, mean difference of 0.5 days (-2.4 to 3.4 days; P=0.74) days. There were no differences in short-term recovery or postoperative morbidity. CONCLUSION Intraperitoneal local anaesthetic did not shorten the time to RIOT among women undergoing surgery for advanced ovarian cancer in this trial. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov (NCT04065009), European Union Clinical Trials Register (2019-003299-38/SE).

中文翻译：

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细胞减灭术期间和手术后腹膜内局部麻醉剂罗哌卡因对晚期卵巢癌辅助化疗时间间隔的影响：一项随机、双盲 III 期试验。


背景 在之前的一项 II 期试验中，腹膜内局部麻醉剂缩短了手术和辅助化疗之间的时间间隔，这是与提高晚期卵巢癌生存率相关的终点。我们的目标是在 III 期试验中对此进行测试。方法 在瑞典的两所大学医院进行了一项双盲、III 期平行优效性试验，位于公共和集中式医疗保健系统内。计划进行细胞减灭术的晚期卵巢癌女性 >18 岁，ASA 身体状况为 1-3 且无言语/语言问题，符合条件。参与者使用中央计算机系统随机分配，在手术期间和手术后腹膜内接受 0.2% 罗哌卡因或 0.9% 生理盐水（安慰剂）。主要终点是恢复预期肿瘤治疗 （RIOT） 的时间，使用 t 检验和线性回归进行分析。结果在 2020 年 8 月至 2023 年 12 月期间随机分配的 225 名女性中（罗哌卡因 n=113;安慰剂 n=112），175 名被纳入改良意向治疗分析（罗哌卡因 n=86;安慰剂 n=89）。中位年龄：罗哌卡因组 64 岁（56-73 岁），安慰剂组：66 岁（57-74 岁）。罗哌卡因组的平均 RIOT 为 26.5 天，安慰剂组为 25.8 天，平均差异为 0.7 天（-2.2 至 3.4 天;P=0.65）。对 166 名女性的符合方案分析产生了相似的结果，平均差异为 0.5 天（-2.4 至 3.4 天;P=0.74） 天。短期恢复或术后发病率无差异。结论 在本试验中，腹腔内局部麻醉剂并未缩短接受晚期卵巢癌手术的女性发生 RIOT 的时间。临床试验注册 临床试验。gov （NCT04065009），欧盟临床试验注册库 （2019-003299-38/SE）。