Opioid-free versus opioid-based anesthesia in laparoscopic bariatric surgery: an exploratory randomized pilot trial
Abstract
Background: Bariatric surgery is the most effective treatment for severe obesity, but perioperative pain control and prevention of postoperative nausea and vomiting (PONV) remain important clinical challenges. Opioid-free anesthesia (OFA) has been proposed as a strategy to reduce opioid-related adverse effects within multimodal perioperative care; however, evidence regarding its clinical benefits in bariatric surgery remains limited and heterogeneous.
Methods: In this prospective exploratory randomized pilot trial, 60 patients undergoing laparoscopic bariatric surgery were allocated in a 1:1 ratio to receive opioid-free anesthesia (OFA) or opioid-based anesthesia (OBA). The primary endpoint was postoperative pain intensity at post-anesthesia care unit (PACU) discharge. Secondary outcomes included pain at additional time points, need for rescue analgesia, PONV, intraoperative nociception assessed using the nociception level (NOL) index, and patient satisfaction. Adjusted analyses were performed using generalized linear and logistic regression models, accounting for clinically relevant baseline imbalances.
Results: Sixty patients were randomized (OFA n = 30; OBA n = 30), with no losses to follow-up. OFA was associated with lower postoperative pain scores at PACU discharge and at 24 h, but not at hospital discharge. Although absolute differences in pain intensity were modest, the need for rescue analgesia was lower in the OFA group (30.0% vs. 73.3%), corresponding to an…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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