Eligibility Details:
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. ASA (American Society of Anesthesiologists) physical status 1, 2, or 3 are able to
provide informed consent, adhere to the study visit schedule, and complete all study
assessments
Exclusion Criteria:
1. Age <18
2. BMI > or equal to 40 or otherwise not anatomically appropriate to undergo a TAP block.
3. Planned general anesthetic
4. Cesarean delivery via vertical skin incision
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 (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 , or serum alanine
aminotransferase [ALT] level >3 times the upper limit of normal.)
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.
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. 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.
16. 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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
