Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
Condition: Elective Cesarean Section; Pain Management
Intervention: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen; 150 mcg Duramorph + multi-modal pain regimen; Exparel TAP + multi-modal pain regimen
Intervention description: Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.; Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.; EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bupivacaine; EXPAREL; analgesic; TAP Block; C-Section; Cesarean Section; elective c-section; TAP

Summary:

      The purpose of this study is to compare total opioid consumption by subjects in different
      treatment groups.

      Another purpose of this study is to assess how well EXPAREL works, collect any safety data
      and assess your satisfaction using EXPAREL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females 18 years of age and older at screening.

          2. Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.

          3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.

          4. Able to provide informed consent, adhere to the study visit schedule, and complete all
             study assessments.

        Exclusion Criteria:

          1. Subjects who, in the opinion of the study site principal investigator, have a
             high-risk pregnancy.

          2. Subjects with a pregnancy-induced medical condition or complication.

          3. Subjects with 3 or more prior C-sections.

          4. Pre-pregnancy body mass index >50 kg/m2.

          5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study
             medications.

          6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or
             tubal ligation.

          7. Severely impaired renal or hepatic function.

          8. Subjects at an increased risk for bleeding or a coagulation disorder.

          9. Concurrent painful physical condition that may require analgesic treatment in the
             postsurgical period for pain that is not strictly related to the surgery.

         10. Clinically significant medical disease in either the mother or baby that, in the
             opinion of the investigator, would make participation in a clinical study
             inappropriate.

         11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

         12. Administration of an investigational drug within 30 days or 5 elimination half-lives
             of such investigational drug.

         13. Previous participation in an EXPAREL study.

         14. Any clinically significant event or condition uncovered during the surgery that might
             render the subject medically unstable or complicate the subject's postsurgical course.

         15. Receives the epidural component of combined spinal epidural (CSE) anesthesia during
             the study.