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

NCT03176459 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 402-C-411
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 12

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.

Conditions

C-Section; Pain Management

Keywords

bupivacaine; exparel; analgesic; TAP Block

Outcome Measures

Primary Outcomes (1)

• Total Postsurgical Opioid Consumption Through 72 Hours After TAP Infiltration During Elective Cesarean Section

  The primary endpoint is the total postsurgical opioid consumption (mg) in oral morphine equivalent dose (OMED) through 72 hours.

  0-72 hours

Secondary Outcomes (8)

• Area Under the Curve (AUC) for Visual Analog Scale (VAS) Pain Scores Through 72 Hours

  0-72 hours

• Opioid Spared Subjects Through 72 Hours

  0-72 hours

• Total Postsurgical Opioid Consumption Through 24 Hours

  0-24 hours

• Total Postsurgical Opioid Consumption Through 48 Hours

  0-48 hours

• Total Postsurgical Opioid Consumption Through 168 Hours (Day 7)

  0-168 hours

Study Arms (2)

EXPAREL+bupivacaine TAP infiltration

EXPERIMENTAL

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

Active bupivacaine TAP infiltration

ACTIVE COMPARATOR

Receive 20 mL 0.25% bupivacaine expanded in volume with 40 mL normal saline for a total volume of 60 mL

Drug: Bupivacaine

Interventions

Exparel + Bupivacaine DRUG

EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.

EXPAREL+bupivacaine TAP infiltration

Bupivacaine DRUG

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.

Active bupivacaine TAP infiltration

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is for subjects undergoing elective Cesarean Section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Subjects with a pregnancy-induced medical condition or complication (eg, hypertension, pre-eclampsia, chorioamnionitis).
• Subjects with 3 or more prior C-sections.
• Pre-pregnancy body mass index \>50 kg/m2 or otherwise not anatomically appropriate to undergo a TAP block.
• 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).
• Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• 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.)
• 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)
• 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.
• 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.
• 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, 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
• 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 criteria during surgery:
• 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.
• Receives the epidural component of CSE anesthesia during participation in the study.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (12)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St. Peter's University Medical Center

New Brunswick, New Jersey, 08901, United States

Location

Columbia Universtiy Medical Center

New York, New York, 10032, United States

Location

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Inova Fairfax Medical Center

Falls Church, Virginia, 22042, United States

Location

West Virginia University School of Medicine

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

• Nedeljkovic SS, Kett A, Vallejo MC, Horn JL, Carvalho B, Bao X, Cole NM, Renfro L, Gadsden JC, Song J, Yang J, Habib AS. Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial. Anesth Analg. 2020 Dec;131(6):1830-1839. doi: 10.1213/ANE.0000000000005075.

  PMID: 32739962 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals

MedInfo@pacira.com

1-855-793-9727

Study Officials

• Hassan Danesi

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-Blind Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: June 1, 2017
• Primary Completion: November 20, 2018
• Study Completion: December 4, 2018
• Last Updated: January 6, 2021
• Results First Posted: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)