Impact of opioid-free anesthesia on the overall benefit of analgesia score after laparoscopic cholecystectomy: protocol and statistical analysis plan for a multicenter, randomized, controlled trial.

INTRODUCTION: Laparoscopic cholecystectomy is frequently complicated by significant postoperative pain and opioid-related adverse events. Whether opioid-free anesthesia (OFA) improves the overall benefit of analgesia in this setting remains unknown. We aim to compare the effects of OFA versus conventional opioid-based anesthesia on the Overall Benefit of Analgesia Score (OBAS) after laparoscopic cholecystectomy. PATIENTS AND METHODS: This multicenter, randomized, controlled trial will enroll 318 adult patients scheduled for elective laparoscopic cholecystectomy at three teaching hospitals in China. Patients will be allocated 1:1 to receive OFA (dexmedetomidine and esketamine) or opioid-based anesthesia (sufentanil). All patients will receive standardized sevoflurane anesthesia and postoperative multimodal analgesia. The primary endpoint is the OBAS at 24 h after surgery. Secondary endpoints include pain scores on movement at 24 h postoperatively and the incidence of chronic pain at 90 days postoperatively. Exploratory endpoints include intraoperative hemodynamics, rescue analgesia, psychiatric adverse events, length of stay in the post-anesthesia care unit, and length of hospital stay. DISCUSSION: Results of this trial will provide high-level evidence on whether the OFA regimen can improve patients' overall analgesic benefit after laparoscopic cholecystectomy. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500099527).