Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section

NCT02353754 | Terminated Phase 4 Results

• 1 other identifier: 402-C-402
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Total Postsurgical Narcotic Consumption in Morphine Equivalents

  Outcome measure data refer to 7 participants who received rescue medication

  Through 72 hours postdose

Secondary Outcomes (2)

• Total Postsurgical Narcotic Consumption in Morphine Equivalents

  Through 24 hours

• Total Postsurgical Narcotic Consumption in Morphine Equivalents

  Through 48 hours

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.

Drug: Intrathecal morphine injection

EXPAREL/TAP

EXPERIMENTAL

Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).

Drug: EXPAREL

Interventions

Intrathecal morphine injection DRUG

0.2 mg

Also known as: Duramorph

Standard of Care

EXPAREL DRUG

266 mg

Also known as: Bupivacaine liposome injectable suspension

EXPAREL/TAP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥18 years of age at screening.
• Scheduled to undergo elective C-section (single or multiple births).
• 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:

• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
• Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
• Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
• Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
• Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
• Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.
• Previous participating in an EXPAREL study.
• The subject will be withdrawn from the study if she meets the following criteria:
• Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
• Her baby's 5-minute Apgar score is ≤7.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (5)

Tradition Medical Center

Port Saint Lucie, Florida, 34987, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Montefiore

The Bronx, New York, 10467, United States

Location

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: James B. Jones, MD, PharmD
• Organization: Pacira Pharmaceuticals Inc.

jim.jones@pacira.com

(973) 254-3560

Study Officials

• Erol Onel, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 3, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 26, 2021
• Results First Posted: June 28, 2016

Record last verified: 2021-03

Locations

US (5)