Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids

Baylor Scott and White Health (BSWH)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Opioid Use

Treatments: Drug: Bilateral abdominal Lap-TAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04655339

019-428

Details and patient eligibility

About

This study evaluates laparoscopic-guided TAP block for reducing opioid use after minimally invasive foregut and bariatric surgeries, comparing Bupivacaine HCL with Exparel®. Secondary outcomes include pain scores, length of stay, and PONV medication use.

Full description

In this study we aim to investigate the efficacy of laparoscopic-guided TAP block in reducing post-operative opioid use following minimally invasive foregut and bariatric surgeries. We will also compare and report the analgesia produced by Bupivacaine HCL vs Exparel ®, a prolonged slow release Liposomal Bupivacaine formulation. Secondary outcomes assessed will be VAS pain scores, length of stay, and PONV dosage administered.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gastric bypass & sleeve gastrectomy, duodenal switch and minimally invasive elective anti-reflux foregut surgeries such as - hiatal hernia repair, fundoplication and Heller myotomy.

Exclusion criteria

• Subjects who are known to be
• Allergic to Bupivacaine
• Chronic opioid users Page 4
• Had/have neurological conditions
• Have a diagnosis of chronic pain syndrome which requires them to consume regular analgesics > 3-months
• American Society of Anesthesiologists (ASA) Class IV & V patients with severe systemic disease that is a constant threat to life.
• Patients with abdominal drain use
• Patients with significant cardiovascular, liver or renal disease
• Presence of contraindications for bariatric or foregut surgery.
• Patients presenting postoperative complications will be excluded from final analysis & final data set
• History of bariatric or foregut surgery
• Patients who are pregnant
• Patients who are under the age of 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Group-1

Experimental group

Description:

Bilateral abdominal Lap-TAP block injection near incision site with 0.25% Bupivacaine HCl (30cc) with 30ml being injected bilaterally. Remaining residual is injected into port incision sites.

Treatment:

Drug: Bilateral abdominal Lap-TAP

Group-2

Experimental group

Description:

Bilateral abdominal Lap-TAP liposomal Bupivacaine (Exparel®) injection with 133mg (20ml) Exparel® plus bupivacaine 0.25% (30ml), plus 10ml of normal saline for a total volume of 60ml, injecting 30ml each side.

Treatment:

Drug: Bilateral abdominal Lap-TAP

Group-3

No Intervention group

Description:

No intervention