NCT03638011

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

A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The investigators will compare the analgesic efficacy and duration of an ultrasound guided bilateral TAP Block (with combined bupivacaine and liposomal bupivacaine) to Duramorph (an opiate). Neuraxial duramorph provides approximately 24 hours of pain relief (analgesia), whereas a bilateral TAP block with liposomal bupivacaine is expected to provide up to 72 hours of analgesia. All participants will have neuraxial anesthesia (either a spinal or epidural) for their non-urgent or elective Cesarean section. The control group (Group 1) will receive either intrathecal or epidural Duramorph (preservative-free morphine sulfate). Post-operatively, participants will have orders to receive, on an as-needed basis, IV/oral acetaminophen and/or IV/oral non-steroidal anti-inflammatory drugs (NSAIDS) for mild-moderate pain, and narcotics for severe pain; specifically- oxycodone or hydromorphone. All patients must receive acetaminophen and NSAIDS (unless contraindicated) before receiving narcotics. This multi-modal pain management regimen is our current standard of care. The experimental group (Group 2) will also receive a spinal or epidural anesthetic. This group will not receive neuraxial Duramorph for post-operative pain. Instead, the patient will receive an ultrasound guided bilateral TAP block with a combination of bupivacaine and liposomal bupivacaine solution immediately after the Cesarean section. Additionally, all participants will receive the same post-operative analgesia orders as group 1.

Conditions

• Caesarean Section

Interventions

Type	Name	Description
DRUG	Exparel	Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL

Timeline

• Start date: 2018-09-25
• Primary completion: 2020-03-31
• Completion: 2020-06-30
• First posted: 2018-08-20
• Last updated: 2022-06-07
• Results posted: 2021-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study