MedDataX Logo

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

NCT ID: NCT04655339

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2021-09-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Bilateral abdominal Lap-TAP

Intervention Type DRUG

A total of 30ml of anesthetic (0.25% Bupivacaine HCL), 0.25% Liposomal Bupivacaine (Exparel®) or control will be injected into the transversus abdominis plane bilaterally. A long spinal needle attached to a 30cc syringe with the TAP block solution or control will be used to inject the patient. The needle puncture will be halfway between the subcostal margin and anterior superior iliac spine at the midclavicular line. With laparoscopic guidance, needle will enter through the skin, external oblique and internal oblique. Once the needle is in place, injection of 30 ml on each side will be applied between the internal oblique and transversus abdominis muscle. The injection of bupivacaine into this abdominal wall induces an observable bulge, indicating accuracy of the procedure. These steps will be repeated on the contralateral side of the abdomen. All patients will receive 10 ml bupivacaine 0.25% pre-incision infiltration.

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.

Group Type EXPERIMENTAL

Bilateral abdominal Lap-TAP

Intervention Type DRUG

A total of 30ml of anesthetic (0.25% Bupivacaine HCL), 0.25% Liposomal Bupivacaine (Exparel®) or control will be injected into the transversus abdominis plane bilaterally. A long spinal needle attached to a 30cc syringe with the TAP block solution or control will be used to inject the patient. The needle puncture will be halfway between the subcostal margin and anterior superior iliac spine at the midclavicular line. With laparoscopic guidance, needle will enter through the skin, external oblique and internal oblique. Once the needle is in place, injection of 30 ml on each side will be applied between the internal oblique and transversus abdominis muscle. The injection of bupivacaine into this abdominal wall induces an observable bulge, indicating accuracy of the procedure. These steps will be repeated on the contralateral side of the abdomen. All patients will receive 10 ml bupivacaine 0.25% pre-incision infiltration.

Group-3

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bilateral abdominal Lap-TAP

A total of 30ml of anesthetic (0.25% Bupivacaine HCL), 0.25% Liposomal Bupivacaine (Exparel®) or control will be injected into the transversus abdominis plane bilaterally. A long spinal needle attached to a 30cc syringe with the TAP block solution or control will be used to inject the patient. The needle puncture will be halfway between the subcostal margin and anterior superior iliac spine at the midclavicular line. With laparoscopic guidance, needle will enter through the skin, external oblique and internal oblique. Once the needle is in place, injection of 30 ml on each side will be applied between the internal oblique and transversus abdominis muscle. The injection of bupivacaine into this abdominal wall induces an observable bulge, indicating accuracy of the procedure. These steps will be repeated on the contralateral side of the abdomen. All patients will receive 10 ml bupivacaine 0.25% pre-incision infiltration.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dan Davis

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

019-428

Identifier Type: -

Identifier Source: org_study_id