A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine
Condition: Caesarean Section
Intervention: Exparel
Intervention description: Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL delivered into the bilateral TAP blocks. TAP blocks are an excellent method for providing adequate analgesia following lower abdominal surgery.
Those patients who wish to participate will be asked to sign a study consent form. Patients that decide to participate in this study will be randomized to either group 1 or group 2 (like the flip of a coin). Both groups will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control.
Masking: None (Open Label)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cesarean Section; Pregnancy

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.
    

Eligibility 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.