Thoracic Epidural-Based Opioid-Free Anesthesia Versus Opioid-Based Balanced Anesthesia for Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Background: Opioid-free anesthesia (OFA) has been proposed to reduce opioid-related adverse effects while maintaining adequate intraoperative hemodynamic stability and postoperative analgesia. We compared epidural-based OFA with opioid-based balanced anesthesia (OBA) in patients undergoing elective laparoscopic cholecystectomy. Materials and Methods: In this prospective, randomized controlled trial, 160 adults scheduled for elective laparoscopic cholecystectomy were randomly assigned (1:1) to receive either OFA with thoracic epidural analgesia ( n = 80) or OBA ( n = 80). The primary outcome was heart rate (HR) immediately after tracheal intubation. Secondary outcomes included mean arterial pressure (MAP), numeric rating scale (NRS), rescue analgesic requirement, quality of recovery (QoR-15), time to mobilization, time to discharge, and adverse events. Analysis was performed using independent-samples tests with adjustment for repeated measures. Results: All randomized patients completed follow-up and were analyzed. HR immediately after intubation was slightly higher in the OFA group (86.7 ± 11.1 vs 83.6 ± 18.2 bpm, P = 0.049), but the change from post-induction values did not differ significantly between groups. MAP was lower in the OFA group at several intraoperative time points. Postoperative NRS scores were significantly lower in the OFA group at all measured time points within 24 h (all P < 0.001), with reduced rescue analgesic use. QoR-15 scores were higher in the OFA group on postoperative day 1 and at discharge (both P < 0.001). Intraoperative hypotension occurred in 6.3% of OFA patients and 0% of OBA patients. Conclusions: Thoracic epidural-based OFA provided a comparable hemodynamic response to intubation, superior postoperative analgesia, and improved recovery compared with OBA but was associated with increased intraoperative hypotension.