Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs

NCT05177991 | Active Not Recruiting Early Phase 1

• 1 other identifier: Anesthesia_Hernia_Pain
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia; Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Subjective Pain Scores using Visual Analog Scale (VAS)

  Lower mean daily post-operative pain scores between participants in the Exparel vs. Bupivacaine arms recorded multiple times over the observation period. The pain scale is 0-10 with 0 being no pain to 10 being the worst pain possible.

  For 1 week post-operation

Secondary Outcomes (2)

• Opioids Used Post-Operatively compared in anesthesia arms

  For 1 Week post-operation

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

  After 1 week post-operation

Study Arms (2)

Liposomal Bupivacaine (Exparel)

ACTIVE COMPARATOR

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.

Drug: Liposomal Bupivacaine

Bupivacaine (Marcaine)

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Interventions

Liposomal Bupivacaine DRUG

20cc of Liposomal Bupivacaine for TAP block

Liposomal Bupivacaine (Exparel)

Bupivacaine DRUG

20cc of Bupivacaine for TAP block

Bupivacaine (Marcaine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Have a ventral or inguinal hernia requiring surgical repair

You may not qualify if:

• Less than 18 years of age
• Chronic pain patients
• Having a defect \>10 cm in transverse dimension
• Having a defect \<4 cm
• Has an allergy to bupivacaine
• Has recurrent hernias as per medical history
• A TAP block performed at any time aside from just prior to the start of the procedure
• If bupivacaine is mixed with other anesthetics
• Under the instance of an emergency surgery (trauma)
• Concomitant surgery
• History of EtOH abuse
• History of liver/kidney dysfunction
• If the procedure must be converted to open
• Inidividual's weight \< 50kg
• Individual's BMI \> 45

Sponsors & Collaborators

• Leslie Son: lead
• Our Lady of the Lake Hospital: collaborator

Study Sites (1)

Karl LeBlanc

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Ventral

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Leslie Son, PhD

  Our Lady of the Lake Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Model Details: Single Blind, randomized

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 5, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)