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OpenTrials
Enrolling by Invitation

NCT Number: NCT07518238

Hernia Abd Wall Recons - BDE vs Exparel

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

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)}.

Treatment and study plan

BDE Injectable Drug

Drug

Bupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction

Exparel Injectable Drug

Drug

Exparel for hernia patients receiving abdominal wall reconstruction

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. Bowel Function

    Time frame: 30-45 days after hospital discharge

    To assess the time to return of bowel function in both groups.

  2. Total Cost

    Time frame: 30-45 days after hospital discharge

    To compare the total cost between the two groups.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.