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Exparel vs. Bupivacaine for Postoperative Pain After Hernia Surgery

Phase < 1

Recruiting

Research Sponsored by Leslie Son

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Have a ventral or inguinal hernia requiring surgical repair

Must not have

Concomitant surgery

Has recurrent hernias as per medical history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 week post-operation

Awards & highlights

No Placebo-Only Group

Summary

This trial found that Exparel provides superior postoperative pain control compared to bupivacaine alone in minimally invasive ventral and inguinal hernia repair patients.

Who is the study for?

This trial is for adults over 18 with ventral or inguinal hernias needing surgery. It's not for those under 18, chronic pain patients, individuals with very large (>10 cm) or small (<4 cm) defects, allergies to bupivacaine, recurrent hernia history, emergency surgeries, other concurrent surgeries, heavy alcohol users, if the procedure turns open surgery, people weighing less than 50kg or with a BMI over 45.

What is being tested?

The study tests two types of TAP blocks in minimally invasive hernia repairs: one using Exparel (Liposomal Bupivacaine), and the other using Marcaine (Bupivacaine). Patients are randomly assigned to receive either treatment to compare postoperative pain control effectiveness.

What are the potential side effects?

Possible side effects include reactions at the injection site like swelling and redness; nerve damage symptoms such as numbness or weakness; and systemic effects like nausea or heart rhythm disturbances due to local anesthetics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I need surgery for a hernia in my abdomen or groin area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am undergoing or scheduled for another surgery.

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I have had hernias come back after treatment.

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I have had liver or kidney problems in the past.

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My BMI is over 45.

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I am under 18 years old.

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I have a wound or defect larger than 10 cm across.

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My weight is less than 50kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 1 week post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 1 week post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 1 week post-operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subjective Pain Scores using Visual Analog Scale (VAS)

Secondary study objectives

Opioids Used Post-Operatively compared in anesthesia arms

Opioids Used Post-Operatively related to Hernia Size and Surgical Time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Liposomal Bupivacaine (Exparel)Active Control1 Intervention

The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.

Group II: Bupivacaine (Marcaine)Active Control1 Intervention

0 / 9Eligibility criteria met