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Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections (C-Section)

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ClinicalTrials.gov Identifier: NCT03176459
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Brief Summary:

Primary objective: The primary objective of this study is to compare total opioid consumption through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration after spinal anesthesia in subjects undergoing an elective cesarean section (C-section).

Secondary objective: The secondary objectives are to assess efficacy and safety parameters and patient satisfaction.


Condition or disease Intervention/treatment Phase
C-Section Pain Management Drug: Exparel + Bupivacaine Drug: Bupivacaine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Double-Blind Study
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) Versus Bupivacaine Alone in Subjects Undergoing Elective Cesarean Section
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: EXPAREL+bupivacaine TAP infiltration
Receive a single 20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL.
Drug: Exparel + Bupivacaine
EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.

Active Comparator: Active bupivacaine TAP infiltration
Receive 20 mL 0.25% bupivacaine expanded in volume with 40 mL normal saline for a total volume of 60 mL
Drug: Bupivacaine
Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.




Primary Outcome Measures :
  1. Total Postsurgical Opioid Consumption [ Time Frame: Through 72 hours ]

Secondary Outcome Measures :
  1. Time to first postsurgical opioid rescue medication [ Time Frame: Through 72 hours ]
  2. VAS pain intensity scores (at rest) [ Time Frame: Through 72 hours ]
  3. Percentage of opioid-free subjects [ Time Frame: Through 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is for subjects undergoing elective Cesarean Section
Accepts Healthy Volunteers:   Yes
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 (eg, multiple gestations, pregnancy resulting from in vitro fertilization, gestational diabetes, end-term prolonged bed rest required for medical reasons).
  2. Subjects with a pregnancy-induced medical condition or complication (eg, hypertension, pre-eclampsia, chorioamnionitis).
  3. Subjects with 3 or more prior C-sections.
  4. Pre-pregnancy body mass index >50 kg/m2 or otherwise not anatomically appropriate to undergo a TAP block.
  5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).
  6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
  7. Severely impaired renal or hepatic function (eg, serum creatinine level >2 mg/dL [176.8 μmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level >3 times the ULN.)
  8. Subjects at an increased risk for bleeding or a coagulation disorder (defined as platelet count less than 80,000 × 103/mm3 or international normalized ratio greater than 1.5)
  9. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and which may confound the postsurgical assessments.
  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. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
  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, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  13. Previous participation in an EXPAREL study.

    In addition, the subject will be ineligible to receive study drug and will be withdrawn from the study if she meets the following criterion during surgery:

  14. Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176459


Contacts
Contact: Hassan Danesi, MD 973-451-4047 Hassan.Danesi@pacira.com
Contact: Jayna Patel 973-451-4059 Jayna.Patel@pacira.com

Locations
United States, California
Loma Linda University Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Mohamed Nour, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Brendan Carvalho, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Srdjan Nedeljkovic, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Srdjan Nedeljkovic, MD         
United States, Michigan
Henry Ford Health Systems Recruiting
Detroit, Michigan, United States, 48202
Contact: Ami Attali, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Leslie Renfro, MD         
United States, New Jersey
St. Peter's University Medical Center Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Attila Kett, MD         
United States, New York
Columbia Universtiy Medical Center Recruiting
New York, New York, United States, 10032
Contact: Richard Smiley, MD         
United States, North Carolina
Duke Regional Hospital Recruiting
Durham, North Carolina, United States, 27704
Contact: Ashraf Habib, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ashraf Habib, MD         
United States, Ohio
Fairview Hospital - Cleveland Clinic Withdrawn
Cleveland, Ohio, United States, 44111
United States, Texas
UT Health Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jerrie Refuerzo, MD         
United States, Virginia
Inova Fairfax Medical Center Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Seyed Shobeiri, MD         
United States, West Virginia
West Virginia University School of Medicine Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Manuel Vallejo, MD         
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Hassan Danesi Pacira Pharmaceuticals

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03176459     History of Changes
Other Study ID Numbers: 402-C-411
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Pacira Pharmaceuticals, Inc:
bupvacaine
exparel
analgesic
TAP Block

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents