Hernia Abd Wall Recons - BDE vs Exparel
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BDE Injectable Drug, Exparel Injectable Drug.
- Who it may be relevant to
- Registry conditions: BDE for Hernia Patients, Exparel for Hernia Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Effectiveness of Bupivacaine-Dexamethasone-Epinephrine Versus Exparel in Postoperative Outcomes for Hernia Patients Undergoing Abdominal Wall Reconstruction
Overview
This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery.
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.
Interventions
- Drug BDE Injectable Drug
Bupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction - Drug Exparel Injectable Drug
Exparel for hernia patients receiving abdominal wall reconstruction
Primary outcome measures
- Morphine Milligram Equivalent [Time frame: 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)]
- Hospital Stay [Time frame: 30-45 days after hospital discharge]
Secondary outcome measures (2)
- Bowel Function [Time frame: 30-45 days after hospital discharge]
- Total Cost [Time frame: 30-45 days after hospital discharge]
Eligibility criteria
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)}.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Baylor University Medical Center — Dallas
Identifiers
NCT: NCT07518238 · 025-448