Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 20 and up Women only

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

PhasePhase2; Phase3
Study typeInterventional
Ages20 Years and up
SexWomen only
Enrollment120 (estimated)
SponsorDalin Tzu Chi General Hospital
Academic / other
Locations1 site (Dalin, Chai-Yi)
StatusRecruiting
StartedMay 6, 2024
Main results expectedMarch 14, 2026
Study endsJune 14, 2026
Registry record updatedMay 9, 2025
Trial IDNCT06344169 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

  • Dalin Tzu Chi Hospital
    Dalin, Chai-Yi, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.