Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section
RecruitingPhase 2, Phase 3NCT06344169
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, …
Study details
- Official title
- 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
- Conditions
- Postsurgical Pain
- Cesarean Section
- Chronic Post-surgical Pain
- Interventions
- Drug: Sebacoyl Dinalbuphine Ester
- Drug: Morphine
- Sponsor
- Dalin Tzu Chi General Hospital
- Start date
- 2024-05-06
- Primary completion
- 2026-03-14
- Sex
- Female
- Age range
- from 20 Years
- Results posted
- No results posted in this snapshot
- Countries
- Taiwan
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * term primipara or multipara who are scheduled for elective cesarean section Exclusion Criteria: 1. Severe pregnancy-induced complication (such as preeclampsia, eclampsia, poorly control pregnancy-induced hypertension and/or diabetes) 2. High risk for postpartum hemorrhage 3. Contraindicated for neuraxial block 4. Preterm (gestational age\< 36 week) delivery 5. Emergency cesarean section 6. After-office hour schedule 7. History of substance abuse 8. Known allergy to nalbuphine, benzyl benzoate or sesame oil 9. Eligible parturient who are not willing to follow the assignment of treatment after randomization
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06344169