Efficacy and safety of extended-release dinalbuphine sebacate in a multimodal analgesic regimen following cesarean section: A prospective observational study

OBJECTIVE: Persistent pain is a frequent outcome following cesarean section, with reported incidence ranging from 6.9% to 30.7% at three months after surgery. Developing novel analgesics with long duration of action, high potency, and a low risk of abuse is crucial. This study investigated the efficacy and safety of dinalbuphine sebacate, a slow-release, long-duration nalbuphine, as part of a multimodal analgesic regimen for post-cesarean section pain control. MATERIALS AND METHODS: In this prospective observational study, participants received either a conventional patient-controlled analgesia regimen with morphine delivered for three days or an adjusted regimen consisting of a single 150 mg dose of dinalbuphine followed by one day of patient-controlled analgesia morphine. Mefenamic acid administered four times daily and supplementary propacetamol were provided in both groups. Participants rated postoperative pain intensity from 0 (no pain) to 10 (worst imaginable) every 4 h on postoperative day one and twice daily on days 2-4, and the area under the curve of pain over time was compared between groups. RESULTS: In total, 33 participants in the control group and 32 in the dinalbuphine sebacate group completed all assessments. Pain intensity over four days did not differ between the two groups (p = 0.238); however, the control group had a significantly higher frequency and total consumption of rescue propacetamol (both p < 0.001). No participant reported persistent pain at three months after surgery, and the incidences of adverse events were comparable between groups. Furthermore, no adverse events were observed in neonates fed with breast milk. CONCLUSION: Dinalbuphine sebacate is safe and effective for post-cesarean pain management when integrated into multimodal analgesic regimens. REGISTRATION: ClinicalTrials.gov Identifier: NCT05009771.