Clinical trial NCT03853694: Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elective Cesarean Section
Pain Management
Keywords: bupivacaine
EXPAREL
analgesic
TAP Block
C-Section
Cesarean Section
elective c-section
TAP
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Females 18 years of age and older at screening.
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:

1. Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
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.

Primary outcomes:
measure: Total Postsurgical Opioid Consumption Through 72 Hours
timeFrame: Through 72 hours post-surgery
Secondary outcomes:
measure: Percentage of Opioid-free Subjects
timeFrame: through 72 hours or hospital discharge, whichever came first
measure: Severity of Itching (Numeric Rating Scale Score)
timeFrame: through 72 hours after surgery
measure: Opioid Related Symptom Distress Scale Score (ORSDS)
timeFrame: through 72 hours after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Gainesville
country: United States
facility: University of Florida- Gainesville
state: Florida
city: Jacksonville
country: United States
facility: University of Florida college of Medicine - Jacksonville
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: St. Peter's University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/NY Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Nayana Nagaraj, MD, PhD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.