NCT06344169 Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section
| NCT ID | NCT06344169 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Dalin Tzu Chi General Hospital |
| Condition | Postsurgical Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2026-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-05-06 with a primary completion date of 2026-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP.
Eligibility Criteria
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
Contact & Investigator
NING-SHENG LAI
STUDY CHAIR
Buddhist Tzu Chi Hospital
Frequently Asked Questions
Who can join the NCT06344169 clinical trial?
This trial is open to female participants only, aged 20 Years or older, studying Postsurgical Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06344169 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06344169 currently recruiting?
Yes, NCT06344169 is actively recruiting participants. Contact the research team at lamcf@mail.ncku.edu.tw for enrollment information.
Where is the NCT06344169 trial being conducted?
This trial is being conducted at Dalin, Taiwan.
Who is sponsoring the NCT06344169 clinical trial?
NCT06344169 is sponsored by Dalin Tzu Chi General Hospital. The principal investigator is NING-SHENG LAI at Buddhist Tzu Chi Hospital. The trial plans to enroll 120 participants.