Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
CHOICE
A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)
1 other identifier
interventional
167
1 country
18
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 and assess your satisfaction using EXPAREL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2019
Shorter than P25 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedStudy Start
First participant enrolled
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2020
CompletedResults Posted
Study results publicly available
July 18, 2022
CompletedJuly 18, 2022
July 1, 2022
10 months
September 19, 2018
April 4, 2022
July 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Postsurgical Opioid Consumption Through 72 Hours
To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section
Through 72 hours post-surgery
Secondary Outcomes (3)
Percentage of Opioid-free Subjects
through 72 hours or hospital discharge, whichever came first
Severity of Itching (Numeric Rating Scale Score)
through 72 hours after surgery
Opioid Related Symptom Distress Scale Score (ORSDS)
through 72 hours after surgery
Study Arms (3)
Group 1 (Standard of Care Group)
ACTIVE COMPARATOR150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration
Group 2 (Duramorph + EXPAREL TAP)
EXPERIMENTAL50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.
Group 3 (EXPAREL TAP)
EXPERIMENTALEXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.
Interventions
Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.
EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Stanford University School of Medicine
Stanford, California, 94305, United States
University of Florida- Gainesville
Gainesville, Florida, 32610, United States
University of Florida college of Medicine - Jacksonville
Jacksonville, Florida, 32209, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
St. Peter's University Medical Center
New Brunswick, New Jersey, 08901, United States
Columbia University Medical Center/NY Presbyterian Hospital
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Thomas Jefferson Medical Center
Philadelphia, Pennsylvania, 19107, United States
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
The University of Texas Medical Branch
Galveston, Texas, 77555-0877, United States
Inova Health System
Falls Church, Virginia, 22042, United States
West Virginia University
Morgantown, West Virginia, 86506, United States
Related Publications (1)
Habib AS, Nedeljkovic SS, Horn JL, Smiley RM, Kett AG, Vallejo MC, Song J, Scranton R, Bao X. Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine. J Clin Anesth. 2021 Dec;75:110527. doi: 10.1016/j.jclinane.2021.110527. Epub 2021 Oct 6.
PMID: 34626927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pacira Medical Information
- Organization
- Pacira Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Nayana Nagaraj, MD, PhD, MPH
Pacira Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
February 26, 2019
Study Start
March 4, 2019
Primary Completion
January 9, 2020
Study Completion
January 16, 2020
Last Updated
July 18, 2022
Results First Posted
July 18, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share