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

Stopped early · Phase 4

Conditions studied: Pain

In brief

This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).

Key facts

Study ID

NCT02353754

Run by

Pacira Pharmaceuticals, Inc

People needed

12

Starts

2015-05-01

Expected to finish

2015-07-01

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females ≥18 years of age at screening.
• Scheduled to undergo elective C-section (single or multiple births).
• American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

You may not qualify if…

• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
• Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
• Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• 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.
• 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.
• 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.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
• 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.
• Previous participating in an EXPAREL study.
• The subject will be withdrawn from the study if she meets the following criteria:
• 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.
• Her baby's 5-minute Apgar score is ≤7.

Where it is running

• Tradition Medical Center — Port Saint Lucie, Florida, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• Montefiore — The Bronx, New York, United States
• The Ohio State University, Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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