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



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:March 4, 2019
End Date:September 2019
Contact:Jennifer Gordon
Email:jennifer.gordon@pacira.com
Phone:973-451-4055

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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)

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.

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.

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.
We found this trial at
10
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Falls Church, Virginia 22042
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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New Brunswick, New Jersey 08901
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Suffolk, Virginia 23434
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