Hernia Abd Wall Recons - BDE vs Exparel

April 2, 2026 updated by: Baylor Research Institute

Comparative Effectiveness of Bupivacaine-Dexamethasone-Epinephrine Versus Exparel in Postoperative Outcomes for Hernia Patients Undergoing Abdominal Wall Reconstruction

This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective randomized controlled trial comparing the outcomes of hernia patients receiving BDE versus Exparel before abdominal wall reconstruction. The study will utilize the pain numeric rating scale (PNRS) validated questionnaire to assess pain levels. Patients will be asked to report their worst pain imaginable.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any preoperative robotic and open abdominal wall surgery patient who will receive a transversus Abdominis Plane (TAP) block in the BSW health care system who agrees to participate in the study
  • Patients 18 years and above

Exclusion Criteria:

  • Patients not undergoing abdominal wall reconstruction surgery
  • Pregnant patients- Patients with childbearing potential undergo serum pregnancy test as per standard of care pre-procedure. If they are found to test positive, they will be excluded from the study.
  • Patients less than 18 years old
  • Patients receiving any additional regional anesthesia outside the study protocol prior to surgery.
  • Patients undergoing additional planned surgical procedures during the same admission
  • History of chronic pain or chronic opioid use Known allergy to BDE or Exparel or to drugs included as part of multimodal regimen { acetaminophen, gabapentin or Lyrica (pregabalin)}.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BDE for hernia patients
112.5 mg of bupivacaine, 3mg dexamethasone and 0.15 mg of epinephrine. In a 30mL syringe. This will be administered into the transversus abdominis plane on both sides.
Drug: BDE Injectable Drug
Bupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction
Active Comparator: Exparel for hernia patients
266mg (20ml) mixed with 30 mls of 0.25% marcaine, administered via syringe in the transversus abdominis plane on both sides.
Drug: Exparel Injectable Drug
Exparel for hernia patients receiving abdominal wall reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Milligram Equivalent
Time Frame: Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
To evaluate the difference in medication usage/ Morphine Milligram Equivalent (MME) between the two groups
Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Pain control
Time Frame: Baseline, Surgery Day, Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Compre efficacy in pain control by using the PNRS Questionniare
Baseline, Surgery Day, Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Hospital Stay
Time Frame: 30-45 days after hospital discharge
To compare the length of hospital, stay between patients receiving BDE and those receiving Exparel.
30-45 days after hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel Function
Time Frame: 30-45 days after hospital discharge
To assess the time to return of bowel function in both groups.
30-45 days after hospital discharge
Total Cost
Time Frame: 30-45 days after hospital discharge
To compare the total cost between the two groups.
30-45 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Bola Aladegbami, MD, Baylor Scott and White Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

November 12, 2029

Study Completion (Estimated)

November 12, 2029

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 025-448

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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