Clinical Trials

Study Title |

A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered via Infiltration into the Transversus Abdominis Plane (TAP) versus Standard of Care (SOC) in Subjects Undergoing Elective Cesarean Section

Primary Objective |

To compare total opioid consumption through 72 hours following EXPAREL® (bupivacaine liposome injectable suspension) infiltration into the TAP with the SOC postsurgical analgesia regimen in subjects undergoing an elective cesarean section (C-section).

Study Summary

Study Status: Startup

NCT Number: NCT03853694

Study Nickname: CHOICE

Enrollment goal

goal

182

Intervention(s)

intervention

EXPAREL, SOC

Phase

phase

4

Condition

condition

Postsurgical pain management

Target Number of Sites: 20

Key Participation Criteria

Gender

gender

Female

Age

≥18years

Time Commitment

time

30 days

Procedures included

procedure

C-section

Inclusion Criteria:

  • 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 physical status 1, 2, or 3
  • Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria:

  • 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 anesthesia during the study

Where to participate

Coordinates

Tampa General Hospital

1 Tampa General Hospital Circle, Suite A327, Tampa, FL 33606

  • Principal Investigator

    Enrico Camporesi, MD

Saint Peter's University Hospital

245 Easton Avenue, New Brunswick, NJ 08901

  • Principal Investigator

    Attila Kett, MD

Massachusetts General Hospital 

55 Fruit Street, Boston, MA 02214

  • Principal Investigator

    Srdjan S. Nedeljkovic, MD

Duke University School of Medicine

2301 Erwin Rd, Durham, NC 27710

  • Principal Investigator

    Ashraf Habib, MD

Sentara OBICI Hospital

2800 Godwin Blvd, Suffolk, VA 23434

  • Principal Investigator

    Ghias Rana, MD

The University of Texas Medical Branch at Galveston

301 University Blvd, Galveston, TX 77555

  • Principal Investigator

    Rovnat Babazade, MD

Inova Health System

3300 Gallows Road, Falls Church, VA 22042

  • Principal Investigator

    Abbas Shobeiri, MD

Brigham and Women's Hospital

75 Francis Street, Boston, MA 02115

  • Principal Investigator

    Srdjan S. Nedeljkovic, MD

University of Florida, Jacksonville

655 West 8th Street; Box C-72, Jacksonville, FL 32209

  • Principal Investigator

    Paul Mongan, MD

Magee-Women’s Hospital of UPMC

300 Halket Street , Pittsburgh, PA 15213

  • Principal Investigator

    Jonathan Waters, MD

West Virginia University

1 Medical Center Drive, PO Box 8255, Morgantown, WV 26505

  • Principal Investigator

    Manuel Vallejo, MD

Columbia University

630 West 168th Street, CHONY North 1121, New York, NY 10032

  • Principal Investigator

    Richard Smiley, MD

Stanford University School of Medicine

300 Pasteur Drive, Stanford, CA 94305

  • Principal Investigator

    Jean-Louis Horn, MD

Clinical Research Prime

187 East 13th Street, Idaho Falls, ID 83404

  • Principal Investigator

    Jeffrey Baker, MD

Closest Location to Participate

Tampa General Hospital
1 Tampa General Hospital Circle, Suite A327, Tampa, FL 33606
  • Principal Investigator

    Enrico Camporesi, MD

Not Yet Recruiting

Saint Peter's University Hospital
245 Easton Avenue, New Brunswick, NJ 08901
  • Principal Investigator

    Attila Kett, MD

Recruiting

Massachusetts General Hospital 
55 Fruit Street, Boston, MA 02214
  • Principal Investigator

    Srdjan S. Nedeljkovic, MD

Recruiting

Duke University School of Medicine
2301 Erwin Rd, Durham, NC 27710
  • Principal Investigator

    Ashraf Habib, MD

Recruiting

Sentara OBICI Hospital
2800 Godwin Blvd, Suffolk, VA 23434
  • Principal Investigator

    Ghias Rana, MD

Not Yet Recruiting

The University of Texas Medical Branch at Galveston
301 University Blvd, Galveston, TX 77555
  • Principal Investigator

    Rovnat Babazade, MD

Recruiting

Inova Health System
3300 Gallows Road, Falls Church, VA 22042
  • Principal Investigator

    Abbas Shobeiri, MD

Not Yet Recruiting

Brigham and Women's Hospital
75 Francis Street, Boston, MA 02115
  • Principal Investigator

    Srdjan S. Nedeljkovic, MD

Recruiting

University of Florida, Jacksonville
655 West 8th Street; Box C-72, Jacksonville, FL 32209
  • Principal Investigator

    Paul Mongan, MD

Recruiting

Magee-Women’s Hospital of UPMC
300 Halket Street , Pittsburgh, PA 15213
  • Principal Investigator

    Jonathan Waters, MD

Not Yet Recruiting

West Virginia University
1 Medical Center Drive, PO Box 8255, Morgantown, WV 26505
  • Principal Investigator

    Manuel Vallejo, MD

Recruiting

Columbia University
630 West 168th Street, CHONY North 1121, New York, NY 10032
  • Principal Investigator

    Richard Smiley, MD

Not Yet Recruiting

Stanford University School of Medicine
300 Pasteur Drive, Stanford, CA 94305
  • Principal Investigator

    Jean-Louis Horn, MD

Recruiting

Clinical Research Prime
187 East 13th Street, Idaho Falls, ID 83404
  • Principal Investigator

    Jeffrey Baker, MD

Recruiting

If you have any questions for clinical trials, please contact clinicaltrials@pacira.com.