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

NCT ID: NCT01801124

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-12-31

Brief Summary

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

Detailed Description

This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.

Conditions

Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXPAREL

undiluted EXPAREL 266 mg

Group Type: EXPERIMENTAL

EXPAREL

Intervention Type: DRUG

single dose 266 mg of undiluted EXPAREL

Interventions

EXPAREL

single dose 266 mg of undiluted EXPAREL

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposome injectable suspension

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Kronenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

MA402S23B702

Identifier Type: -

Identifier Source: org_study_id