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

Launched by PACIRA PHARMACEUTICALS, INC · Jan 29, 2015

Keywords

ClinConnect Summary

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...

Gender

FEMALE

Eligibility criteria

• 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.