BDE for Hernia Patients, Exparel for Hernia Patients
Conditions
Brief summary
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
DRUGBDE Injectable Drug
Bupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction
DRUGExparel Injectable Drug
Exparel for hernia patients receiving abdominal wall reconstruction
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)}.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Milligram Equivalent | 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 |
| Pain control | 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 |
| Hospital Stay | 30-45 days after hospital discharge | To compare the length of hospital, stay between patients receiving BDE and those receiving Exparel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Function | 30-45 days after hospital discharge | To assess the time to return of bowel function in both groups. |
| Total Cost | 30-45 days after hospital discharge | To compare the total cost between the two groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBola Aladegbami, MD
Baylor Scott and White Health
Outcome results
None listed