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

Efficacy of Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids Following Bariatric and Minimally Invasive Foregut Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Opioid Use
• Intervention / Treatment: Drug: Bilateral abdominal Lap-TAP

Detailed Description

In this study the investigators aim to investigate the efficacy of laparoscopic-guided TAP block in reducing post-operative opioid use following minimally invasive foregut and bariatric surgeries. The investigators 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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group-1; 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.	Drug: Bilateral abdominal Lap-TAP; Subjects will have Liposomal Bupivacaine (Exparel®) or the control injected into the transversus abdominis plane bilaterally.
Experimental: Group-2; 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.	Drug: Bilateral abdominal Lap-TAP; Subjects will have Liposomal Bupivacaine (Exparel®) or the control injected into the transversus abdominis plane bilaterally.
No Intervention: Group-3; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid dosage requested	opioid dosage requested post-TAP block	30days

Secondary Outcome Measures

Outcome Measure	Time Frame
visual analog scores (VAS)	30days
length of stay	30days
anti-emetic dosage	30days

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 019-428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes