2.1. Setting and participants
Cancer
ADVERSE EVENTS, CANCER
This phase II/III randomized, double-blind, placebo-controlled clinical trial was conducted in E-Da Hospital and E-Da Cancer Hospital (Kaohsiung, Taiwan) from August 2021 to April 2022. Adult patients aged 20 to 65 years with American Society for Anesthesiologist physical statuses ≤ III who were scheduled for laparoscopic cholecystectomies. This study included patients who were anticipated to stay in the hospital for > 72 hours after operation for feasibility to observe the analgesic effect and potential drug-related adverse events following administration of study drugs. The study was approved by the institutional review board of the E-Da Hospital, Kaohsiung, Taiwan (approval number EMRP28110N). The trial was registered in March 2021 with Clinicaltrials.gov registration: NCT04808544. All participants provided written informed consent before the commencement of the study.