Overview

A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine

Status:
Terminated
Trial end date:
2020-06-30
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Maimonides Medical Center
Treatments:
Analgesics
Bupivacaine
Morphine
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

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.