A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine
Stopped early · Phase 4
Conditions studied: Caesarean Section
In brief
The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pain control and will significantly reduce the use of post-operative IV or p.o. opiates. This is a prospective, randomized clinical trial.
Key facts
- Study ID
- NCT03638011
- Run by
- Maimonides Medical Center
- People needed
- 71
- Starts
- 2018-09-25
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2022-06-07
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Females, aged 18-45 years inclusive and ASA physical status 1-3.
- Undergoing non-urgent Cesarean section with neuraxial anesthesia/analgesia.
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
You may not qualify if…
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a bilateral TAP infiltration.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of NSAIDs.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Where it is running
- Kalpana Tyagaraj — Brooklyn, New York, United States
- Maimonides Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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