• Emma Hasselgren, Nina Groes-Kofoed, Henrik Falconer, Håkan Björne, Diana Zach, Daniel Hunde, Hemming Johansson, Mihaela Asp, Päivi Kannisto, Anil Gupta, and Sahar Salehi.
• Department of Physiology and Pharmacology, Division of Anaesthesiology, Karolinska Institutet, Stockholm, Sweden, Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: emma.hasselgren@regionstockholm.se.
• Br J Anaesth. 2024 Nov 20.

BackgroundIn 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.MethodsA 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.ResultsOf 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.ConclusionIntraperitoneal local anaesthetic did not shorten the time to RIOT among women undergoing surgery for advanced ovarian cancer in this trial.Clinical Trial RegistrationClinicalTrials.gov (NCT04065009), European Union Clinical Trials Register (2019-003299-38/SE).Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

7 keywords...

hide…