Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section

Completed · Phase 4

Conditions studied: Elective Cesarean Section, Pain Management

In brief

The purpose of this study is to compare total opioid consumption by subjects in different treatment groups. Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.

Key facts

Study ID

NCT03853694

Run by

Pacira Pharmaceuticals, Inc

People needed

167

Starts

2019-03-04

Expected to finish

2020-01-16

Last updated by the study team

2022-07-18

Who can join

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

You may qualify if…

• Females 18 years of age and older at screening.
• Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
• 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…

• Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
• Subjects with a pregnancy-induced medical condition or complication.
• Subjects with 3 or more prior C-sections.
• Pre-pregnancy body mass index >50 kg/m2.
• Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
• Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• Severely impaired renal or hepatic function.
• Subjects at an increased risk for bleeding or a coagulation disorder.
• Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.
• 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.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug.
• Previous participation in an EXPAREL study.
• Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.
• Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• University of Florida- Gainesville — Gainesville, Florida, United States
• University of Florida college of Medicine - Jacksonville — Jacksonville, Florida, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• St. Peter's University Medical Center — New Brunswick, New Jersey, United States
• Columbia University Medical Center/NY Presbyterian Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson Medical Center — Philadelphia, Pennsylvania, United States
• Magee-Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• The University of Texas Medical Branch — Galveston, Texas, United States
• Inova Health System — Falls Church, Virginia, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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