EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair

NCT01801124 | Completed Phase 4 Results

• 1 other identifier: MA402S23B702
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).

Conditions

Hernia

Keywords

analgesia; hernia repair

Outcome Measures

Primary Outcomes (1)

• Overall Postsurgical Analgesic Use

  The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)

  10 days

Secondary Outcomes (1)

• Postsurgical AEs and SAEs Through Day 30.

  30 days

Study Arms (1)

EXPAREL

EXPERIMENTAL

undiluted EXPAREL 266 mg

Drug: EXPAREL

Interventions

EXPAREL DRUG

single dose 266 mg of undiluted EXPAREL

Also known as: bupivacaine liposome injectable suspension

EXPAREL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
• Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
• Abdominal incision length of 3-12 cm.
• Subjects must be physically and mentally able to participate in the study and complete all study assessments.
• Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.

You may not qualify if:

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
• Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
• Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
• Any female subject who is currently pregnant.
• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Hernia; Agnosia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mark Kronefeld, MD
• Organization: Maimonides Medical Center

(718) 283-8816

Study Officials

• Mark Kronenfeld, MD

  Maimonides

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 8, 2021
• Results First Posted: September 11, 2013

Record last verified: 2021-02

Locations

US (1)