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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Hernia

Intervention / Treatment
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* Drug: EXPAREL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPAREL<br>undiluted EXPAREL 266 mg | Drug: EXPAREL<br>* single dose 266 mg of undiluted EXPAREL<br>* Other names: bupivacaine liposome injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, hernia repair