Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section

Launched by DALIN TZU CHI GENERAL HOSPITAL · Mar 27, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section" is looking at a new way to manage pain for women who have just had a cesarean section (C-section). The goal is to see if Naldebain, a medication that can provide long-lasting pain relief, is as effective as the standard medication currently used, which is intrathecal morphine (ITM). This study is important because effective pain management after surgery can help women recover better, take care of their newborns, and reduce the risk of developing ongoing pain issues later on.

To participate in this trial, women must be scheduled for an elective C-section and be either having their first baby or any subsequent babies. However, there are certain conditions that would exclude them, such as severe complications during pregnancy or a history of substance abuse. Participants can expect to receive either Naldebain or the standard pain management and will be monitored to see how well each option works for controlling pain after their surgery. This trial is not yet recruiting participants, but it aims to improve pain relief options for new mothers in the future.

Gender

FEMALE

Eligibility 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