Pain management after cesarean section using Dinalbuphine Ester
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
Run by Dalin Tzu Chi General Hospital · NCT06344169 · Data updated 2026-11-12
This study is testing if a new pain medication called Dinalbuphine Ester can help women recover better and feel less pain after having a cesarean section compared to standard morphine.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Dalin Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Dalin, Chai-Yi) |
| Status | Recruiting |
| Started | May 6, 2024 |
| Main results expected | March 14, 2026 |
| Study ends | June 14, 2026 |
| Registry record updated | May 9, 2025 |
| Trial ID | NCT06344169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are term primipara or multipara women scheduled for elective cesarean sections.
✕Probably not a fit
Patients with severe pregnancy complications, contraindications for neuraxial block, or those undergoing emergency cesarean sections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of Dinalbuphine Ester (Naldebain) for managing postoperative pain in women undergoing elective cesarean sections. The study aims to compare the analgesic effects of Dinalbuphine Ester with standard morphine treatment, focusing on reducing the incidence of chronic post-surgical pain and improving overall recovery. Participants will be monitored for pain levels and any side effects associated with the treatments. The trial is designed to provide insights into better pain management strategies for postpartum women.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management options for women after cesarean sections, potentially reducing the risk of chronic pain and enhancing recovery.
How similar studies have gone: Other studies have shown varying success with different analgesic approaches for postoperative pain management, but this specific use of Dinalbuphine Ester is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Dalin Tzu Chi Hospital
Dalin, Chai-Yi, Taiwan Recruiting
Study contacts
- Study coordinator: Chen-Fuh Lam, MD, PhD
- Email: lamcf@mail.ncku.edu.tw
- Phone: 8865-2648000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effects of massage and exercises on cesarean scar and recovery
This study tests whether direct scar massage or indirect massage plus exercise helps people recover after a cesarean birth and reduces scar-related pain.
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Reflexology and hand massage after cesarean section
This study tests whether reflexology hand massage or stroking hand massage can reduce anxiety and increase satisfaction, and how they affect heart/blood pressure after cesarean delivery.
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Health education to see if primigravida women choose vaginal delivery more often
A health education program is being tested to see if it helps first-time pregnant women in choosing vaginal delivery over unnecessary cesareans.
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Enhanced Recovery Adherence and Recovery Quality After Cesarean Delivery
This study tests whether following enhanced recovery after cesarean delivery protocols is linked with better recovery quality in women having a planned cesarean with spinal anesthesia.
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Predictors of severe pain within 24 hours after cesarean delivery with spinal anesthesia
This study will look at which pre-, intra-, and post-operative factors are linked to severe pain in the first 24 hours after an elective cesarean done with spinal anesthesia.
-
Steri-Strips added to standard wound closure after cesarean delivery
This study tests whether adding Steri-Strips after a C-section helps reduce wound problems for pregnant patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.