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

Hernia Clinical Trial

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Official title:

Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801124
• Other study ID #: MA402S23B702
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2021
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal

Intervention

Drug:
• EXPAREL
single dose 266 mg of undiluted EXPAREL

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postsurgical AEs and SAEs Through Day 30.	Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.	30 days