Status:
COMPLETED
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Elective Cesarean Section
Pain Management
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
This is a Phase-4, multicenter, randomized, active-controlled study in approximately 182 adult women undergoing elective C-section. All subjects will remain in the hospital for up to 72 hours post sur...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT03853694
Start Date
March 4 2019
End Date
January 16 2020
Last Update
July 18 2022
Active Locations (18)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
University of Florida- Gainesville
Gainesville, Florida, United States, 32610
3
University of Florida college of Medicine - Jacksonville
Jacksonville, Florida, United States, 32209
4
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404