Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
NCT ID: NCT03853694
Last Updated: 2022-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
167 participants
INTERVENTIONAL
2019-03-04
2020-01-16
Brief Summary
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Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.
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Detailed Description
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Subjects will be screened within 30 days prior to surgery. During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation.
After the Informed Consent Form (ICF) is signed, a medical history, surgical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, alcohol breath test and urine drug screen, and clinical laboratory tests (hematology and chemistry) will be performed.
On Day 1, prior to the C-section, eligible subjects will be randomized in a 1:1:1 ratio into one of the three treatment groups listed below:
* Group 1: 150 mcg Duramorph® (SOC arm)+ postoperative multi-modal pain regimen as defined in this protocol. No EXPAREL TAP infiltration following skin-incision closure.
* Group 2: 50 mcg Duramorph + EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol.
* Group 3: EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol. No Duramorph.
Rescue Medication will be provided, as needed, for all subjects.
Subjects will remain in the hospital for up to 72 hours after surgery.
Total opioid burden and Pain intensity scores using a 10 cm Visual Analog Scale (VAS) will be collected.
Daily pain intensity score (VAS) and all pain medications will be collected through Day 14.
A phone call will be made to each subject on Day 14 and Day 30.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (Standard of Care Group)
150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration
150 mcg Duramorph + multi-modal pain regimen
Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.
Group 2 (Duramorph + EXPAREL TAP)
50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.
50 mcg Duramorph+ EXPAREL + multi-modal pain regimen
Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Group 3 (EXPAREL TAP)
EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.
Exparel TAP + multi-modal pain regimen
EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Interventions
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50 mcg Duramorph+ EXPAREL + multi-modal pain regimen
Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.
150 mcg Duramorph + multi-modal pain regimen
Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.
Exparel TAP + multi-modal pain regimen
EXPAREL administered via TAP infiltration + multi-modal pain regimen.
Eligibility Criteria
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Inclusion Criteria
2. Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
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
2. Subjects with a pregnancy-induced medical condition or complication.
3. Subjects with 3 or more prior C-sections.
4. Pre-pregnancy body mass index \>50 kg/m2.
5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
7. Severely impaired renal or hepatic function.
8. Subjects at an increased risk for bleeding or a coagulation disorder.
9. Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.
10. 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.
11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
12. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug.
13. Previous participation in an EXPAREL study.
14. Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.
15. Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study.
18 Years
FEMALE
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Nayana Nagaraj, MD, PhD, MPH
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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402-C-414
Identifier Type: -
Identifier Source: org_study_id
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