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

There will be two groups of subjects with approximately 40 subjects per group. Prior to the
C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl
0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal
morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal
anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will
receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in
volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each
side of the abdomen).

Inclusion Criteria:

1. Females ≥18 years of age at screening.

2. Scheduled to undergo elective C-section (single or multiple births).

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. 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.