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

PHASE4CompletedINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

March 4, 2019

Primary Completion Date

January 9, 2020

Study Completion Date

January 16, 2020

Conditions
Elective Cesarean SectionPain Management
Interventions
DRUG

50 mcg Duramorph+ EXPAREL + multi-modal pain regimen

Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.

DRUG

150 mcg Duramorph + multi-modal pain regimen

Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.

DRUG

Exparel TAP + multi-modal pain regimen

EXPAREL administered via TAP infiltration + multi-modal pain regimen.

Trial Locations (18)

10032

Columbia University Medical Center/NY Presbyterian Hospital, New York

15213

Magee-Women's Hospital of UPMC, Pittsburgh

19107

Thomas Jefferson Medical Center, Philadelphia

22042

Inova Health System, Falls Church

27710

Duke University Medical Center, Durham

32209

University of Florida college of Medicine - Jacksonville, Jacksonville

32610

University of Florida- Gainesville, Gainesville

43210

Ohio State University, Columbus

44195

Cleveland Clinic, Cleveland

48202

Henry Ford Hospital, Detroit

83404

Clinical Research Prime, Idaho Falls

86506

West Virginia University, Morgantown

94305

Stanford University School of Medicine, Stanford

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

08901

Robert Wood Johnson Medical School, New Brunswick

St. Peter's University Medical Center, New Brunswick

77555-0877

The University of Texas Medical Branch, Galveston

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY