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

Phase 2

• Conditions: Opioid Use
• Interventions: Drug: Bilateral abdominal Lap-TAP

• Registration Number: NCT04655339
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Last Update Submitted: 2020-11-30
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-07
• Study Start: 2020-12-10
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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 i. Allergic to Bupivacaine ii. Chronic opioid users Page 4 iii. Had/have neurological conditions iv. Have a diagnosis of chronic pain syndrome which requires them to consume regular analgesics > 3-months v. American Society of Anesthesiologists (ASA) Class IV & V patients with severe systemic disease that is a constant threat to life.

vi. Patients with abdominal drain use vii. Patients with significant cardiovascular, liver or renal disease viii. Presence of contraindications for bariatric or foregut surgery. ix. Patients presenting postoperative complications will be excluded from final analysis & final data set x. History of bariatric or foregut surgery xi. Patients who are pregnant xii. Patients who are under the age of 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-1	Bilateral abdominal Lap-TAP	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.
Group-2	Bilateral abdominal Lap-TAP	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.

Primary Outcome Measures

Name	Time	Method
opioid dosage requested	30days	opioid dosage requested post-TAP block

Secondary Outcome Measures

Name	Time	Method
length of stay	30days
visual analog scores (VAS)	30days
anti-emetic dosage	30days