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Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section

RecruitingPhase 2, Phase 3Ages 20 Years - anyFemaleDalin Tzu Chi General Hospital
NCT06344169 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 eff

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📋 Eligibility rules (as published)
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
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What it tests

  • Sebacoyl Dinalbuphine Ester
  • Morphine
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Where

1 site
Dalin Tzu Chi Hospital
Dalin, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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