Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section

Exclusion Criteria

• •1. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
• •2. Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
• •3. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• •4. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
• •5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
• •6. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
• •7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
• •8. Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.
• •9. Previous participating in an EXPAREL study.
• •The subject will be withdrawn from the study if she meets the following criteria:
• •10. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
• •11. Her baby's 5-minute Apgar score is ≤7.