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New treatment option for Postsurgical Pain
Official title Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section
ClinicalTrials.gov ID: NCT06344169
What this study is testing
What is Sebacoyl Dinalbuphine Ester?
Sebacoyl Dinalbuphine Ester is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postsurgical pain.
Also referred to as Naldebain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older, women only
You may be able to join if
- term primipara or multipara who are scheduled for elective cesarean section
You likely can't join if
- Severe pregnancy-induced complication (such as preeclampsia, eclampsia, poorly control pregnancy-induced hypertension and/or diabetes)
- High risk for postpartum hemorrhage
- Contraindicated for neuraxial block
- Preterm (gestational age\< 36 week) delivery
- Emergency cesarean section
- After-office hour schedule
See the full eligibility criteria
- term primipara or multipara who are scheduled for elective cesarean section
- Severe pregnancy-induced complication (such as preeclampsia, eclampsia, poorly control pregnancy-induced hypertension and/or diabetes)
- High risk for postpartum hemorrhage
- Contraindicated for neuraxial block
- Preterm (gestational age\< 36 week) delivery
- Emergency cesarean section
- After-office hour schedule
- History of substance abuse
- Known allergy to nalbuphine, benzyl benzoate or sesame oil
- Eligible parturient who are not willing to follow the assignment of treatment after randomization
The study team makes the final eligibility decision.
Where it's taking place
- Dalin, Chai-Yi, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dalin, Chai-Yi, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.