Pain management after cesarean section using Dinalbuphine Ester
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
PHASE2; PHASE3 · Dalin Tzu Chi General Hospital · NCT06344169
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 |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Dalin Tzu Chi General Hospital (other) |
| Locations | 1 site (Dalin, Chai-Yi) |
| Trial ID | NCT06344169 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are term primipara or multipara women scheduled for elective cesarean sections.
Not a fit: Patients with severe pregnancy complications, contraindications for neuraxial block, or those undergoing emergency cesarean sections may not benefit from this study.
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 performed: Other studies have shown varying success with different analgesic approaches for postoperative pain management, but this specific use of Dinalbuphine Ester is relatively novel.
Eligibility criteria
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 this trial is running
Dalin, Chai-Yi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postsurgical Pain, Cesarean Section, Chronic Post-surgical Pain, kappa agonist, mu agonist, Intrathecal morphine