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

Phase 4

Completed

• Conditions: Hernia
• Interventions: Drug: EXPAREL

• Registration Number: NCT01801124
• Lead Sponsor: Pacira Pharmaceuticals, Inc

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-02-28
• Results First Submitted: 2013-07-02
• Results First Submitted QC: 2013-07-02
• Results First Posted: 2013-09-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXPAREL	EXPAREL	undiluted EXPAREL 266 mg

Primary Outcome Measures

Name	Time	Method
Overall Postsurgical Analgesic Use	10 days	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)

Secondary Outcome Measures

Name	Time	Method
Postsurgical AEs and SAEs Through Day 30.	30 days	Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States