Exparel vs. Bupivacaine for Postoperative Pain After Hernia Surgery

Overseen By Christine LeBoeuf, DNP

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Leslie Son

Disqualifiers: Chronic pain, Allergy to bupivacaine, Recurrent hernias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.

Research Team

Leslie Son, PhD

Principal Investigator

Our Lady of the Lake Hospital

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

My bupivacaine is mixed with other anesthetics.

I have had a TAP block, but not right before my procedure.

You have a defect that is smaller than 4 centimeters.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive ventral or inguinal hernia repair with a TAP block using either Exparel or Marcaine

1 day

1 visit (in-person)

Post-operative Monitoring

Participants complete VAS pain assessments and record narcotic use at home, with daily follow-up calls from the study team

1 week

Daily virtual follow-ups

Follow-up

Participants return for a follow-up visit to provide VAS assessments and unused narcotics

1 week

1 visit (in-person)

Treatment Details

Interventions

• Bupivacaine
• Liposomal Bupivacaine

Trial Overview 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.

Participant Groups

Group I: Liposomal Bupivacaine (Exparel) Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Leslie Son

Lead Sponsor

Trials

1

Recruited

200+

Our Lady of the Lake Hospital

Collaborator

Trials

15

Recruited

900+

Our Lady of the Lake Regional Medical Center

Collaborator

Trials

6

Recruited

470+