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

Maimonides Medical Center

Status and phase: Terminated; Phase 4

Conditions: Caesarean Section

Treatments: Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT03638011

2018-04-01-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.

Bilateral TAP Block

Active Comparator group

Description:

These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.

Treatment:

Drug: Exparel