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

NCT04655339 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 019-428
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• opioid dosage requested

  opioid dosage requested post-TAP block

  30days

Secondary Outcomes (3)

• visual analog scores (VAS)

  30days

• length of stay

  30days

• anti-emetic dosage

  30days

Study Arms (3)

Group-1

EXPERIMENTAL

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

Group-2

EXPERIMENTAL

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

Group-3

NO INTERVENTION

No intervention

Interventions

Bilateral abdominal Lap-TAP DRUG

Subjects will have Liposomal Bupivacaine (Exparel®) or the control injected into the transversus abdominis plane bilaterally.

Group-1; Group-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: January 24, 2020
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)