Efficacy of Parenteral Injection of an Extended Release Kappa-receptor Opioid Sebacoyl Dinalbuphine Ester for Pain Management After Cesarean Section: a Randomized, Open-label, Non-inferiority Trial

What this Trial Is About

Severe pain after cesarean section can cause physical and emotional distress, slow wound healing, and increase risks like delirium and blood clots. It may also lead to chronic post-surgical pain (CPSP), which can result in longer opioid use and higher healthcare costs. Postoperative pain can reduce a mother's willingness to breastfeed and care for her baby. This trial aims to study the pain relief effects of a new drug called Naldebain42, compared to standard morphine treatment, to manage pain and prevent CPSP in women having elective cesarean sections. Participants will receive either a single intramuscular injection of Naldebain42 (Sebacoyl dinalbuphine ester) or a single intrathecal injection of morphine during spinal anesthesia. Naldebain42 is a long-acting drug that slowly releases nalbuphine over about six days, potentially providing longer pain relief than morphine, which lasts 8-12 hours but can cause side effects like nausea and breathing problems. The study is open-label and randomized, comparing these two pain control methods after cesarean delivery. During the study, participants' pain intensity and need for extra pain medication will be measured for five days after surgery. Researchers will also check for chronic pain occurrence and quality of life three months after delivery. The study includes physical exams, questionnaires, and close monitoring of side effects. Participation lasts through the immediate postoperative period and follow-up at three months to assess long-term pain outcomes and overall satisfaction with pain management.

Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section