A Randomized Controlled Non-Inferiority Trial Evaluating Opioid-Free versus Opioid-Sparing Analgesia for Orbital Fracture Reconstruction Under General Anesthesia.

BACKGROUND AND OBJECTIVES

Opioid-minimizing strategies are making their appearance in enhanced recovery after surgery. This study is aimed to explore the potential advantages of opioid-free analgesia (OFA) compared to opioid-sparing analgesia (OSA) in patients undergoing orbital fracture reconstruction.

METHODS

In this prospective, single-center, randomized controlled study, we randomly recruited 122 patients undergoing orbital fracture reconstruction under general anesthesia. Patients received total intravenous anesthesia with a flexible laryngeal mask airway, and multimodal analgesia with either OSA or OFA methods. The OSA group (n = 61) received low doses of fentanyl and nonsteroidal anti-inflammatory drugs (NSAIDs), and the OFA group (n = 61) received medial canthus peribulbar block (MCPB) combined with NSAIDs. The primary outcomes consisted of area-under-the-curve (AUC) of the numerical rating scale (NRS) pain score, and the incidence of postoperative nausea and vomiting (PONV) through the first 24h.

RESULTS

Compared to the OSA group, the OFA group demonstrated non-inferiority in postoperative analgesia through the first 24 postoperative hours (difference of the medians, -6; 95% confidence interval [CI], -12 to 6), but failed to meet the non-inferiority criterion in the incidence of PONV (difference ratio, 3%; 95% CI, -7% to 14%). The Quality of Recovery-40 questionnaire (QoR-40) scores on postoperative day 1 was significantly higher in group OFA compared to group OSA (188 [178 to 196] vs 181 [169 to 191], respectively; = 0.005).

CONCLUSION

In orbital fracture reconstruction, both OFA and OSA strategies provide effective postoperative pain relief, but OFA using MCPB combined NSAIDs enhances the quality of early postoperative recovery.

REGISTERED

Chinese Clinical Trial Registry ChiCTR1900028088.