Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections
Condition: C-Section; Pain Management
Intervention: Exparel + Bupivacaine; Bupivacaine
Intervention description: EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.; Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Double-Blind Study
Enrollment: 186.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bupivacaine; exparel; analgesic; TAP Block

Summary:

      Primary objective: The primary objective of this study is to compare total opioid consumption
      through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus
      abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration
      after spinal anesthesia in subjects undergoing an elective cesarean section (C-section).

      Secondary objective: The secondary objectives are to assess efficacy and safety parameters
      and patient satisfaction.
    

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 (eg, multiple gestations, pregnancy resulting from in vitro
             fertilization, gestational diabetes, end-term prolonged bed rest required for medical
             reasons).

          2. Subjects with a pregnancy-induced medical condition or complication (eg, hypertension,
             pre-eclampsia, chorioamnionitis).

          3. Subjects with 3 or more prior C-sections.

          4. Pre-pregnancy body mass index >50 kg/m2 or otherwise not anatomically appropriate to
             undergo a TAP block.

          5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study
             medications for which an alternative is not named in the protocol (eg, amide-type
             local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).

          6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or
             tubal ligation.

          7. Severely impaired renal or hepatic function (eg, serum creatinine level >2 mg/dL
             [176.8 μmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate
             aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum
             alanine aminotransferase [ALT] level >3 times the ULN.)

          8. Subjects at an increased risk for bleeding or a coagulation disorder (defined as
             platelet count less than 80,000 × 103/mm3 or international normalized ratio greater
             than 1.5)

          9. Concurrent painful physical condition that may require analgesic treatment (such as
             long-term, consistent use of opioids) in the postsurgical period for pain that is not
             strictly related to the surgery and which may confound the postsurgical assessments.

         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. This includes any psychiatric or other disease in the mother that would
             constitute a contraindication to participation in the study or cause the mother to be
             unable to comply with the study requirements.

         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, whichever is longer, prior to study drug administration,
             or planned administration of another investigational product or procedure during the
             subject's participation in this study

         13. Previous participation in an EXPAREL study. In addition, the subject will be
             ineligible to receive study drug and will be withdrawn from the study if she meets the
             following criteria during surgery:

         14. Any clinically significant event or condition uncovered during the surgery (eg,
             excessive bleeding, acute sepsis) that might render the subject medically unstable or
             complicate the subject's postsurgical course.

         15. Receives the epidural component of CSE anesthesia during participation in the study.