Hernia Abd Wall Recons - BDE vs Exparel

Baylor Scott and White Health (BSWH)

Status and phase: Invitation-only; Phase 2

Conditions: Exparel for Hernia Patients; BDE for Hernia Patients

Treatments: Drug: BDE Injectable Drug; Drug: Exparel Injectable Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT07518238

025-448

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)}.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

BDE for hernia patients

Active Comparator group

Description:

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.

Treatment:

Drug: BDE Injectable Drug

Exparel for hernia patients

Active Comparator group

Description:

266mg (20ml) mixed with 30 mls of 0.25% marcaine, administered via syringe in the transversus abdominis plane on both sides.

Treatment:

Drug: Exparel Injectable Drug