Efficacy and safety of extended-release dinalbuphine sebacate for postoperative analgesia: A systematic review and meta-analysis

Abstract

Background: Multimodal analgesia, which combines multiple medications with different analgesic mechanisms, is recommended for optimizing postoperative pain control and minimizing opioid-related side effects. Dinalbuphine sebacate (DNS), a prodrug of nalbuphine, has a 7-day long-acting analgesic effect on moderate to severe postoperative pain. We conducted a systematic review and meta-analysis to analyze the efficacy and safety of DNS for postoperative pain management. Materials and Methods: We systematically searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials of DNS for postoperative analgesia. We assessed the quality of all included studies using the risk-of-bias tool. The primary outcome was postoperative pain score, and the secondary outcomes included analgesic consumption, need for rescue analgesics, adverse events, and length of hospital stay. A meta-analysis was performed for the pooled data, and the level of evidence was rated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. Results: We included five randomized controlled trials with 497 patients who underwent surgery. Compared with the control group, DNS significantly reduced the visual analog scale from postoperative 48 hours {mean difference (MD): -37.54 (95% confidence interval [CI]: -70.47, -4.62)} to 7 days [MD: -165.99 (95% CI: -231.44)] and decreased the requirement for rescue analgesics [relative risk: 0.89 (95% CI: 0.81, 0.97)]. No significant difference was observed in visual analog scale scores within postoperative 24 hours [MD: -10.13 (95% CI: -30.11, 9.85)] or in total analgesic consumption. Patients receiving DNS had a higher risk of dizziness and injection site reactions, without an increased occurrence of other adverse events. Conclusions: With a low to moderate level of evidence, intramuscular DNS provides long-lasting analgesia from postoperative 48 hours to 7 days and may reduce the requirement for postoperative rescue analgesics. However, DNS does not offer additional pain relief within the first 24 hours postoperatively. Further high-quality studies are warranted.