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Painkiller-Sparing nerve block trial pulled before it began

NCT ID NCT04655339

Symptom relief Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study planned to test a laparoscopic-guided nerve block (TAP block) to reduce opioid painkiller use after weight-loss or anti-reflux stomach surgeries. It compared two numbing medicines, Bupivacaine HCL and Exparel. However, the trial was withdrawn before enrolling any participants, so no data were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liposomal Bupivacaine (Exparel) and Bupivacaine HCL
What this could lead to
If it had worked, this could point toward a way to reduce opioid painkiller use after certain stomach surgeries.
What could go wrong
The trial was withdrawn before it started, so no results are available. It is unclear if the approach is effective or safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Started

Jan 2020

Finished

Sep 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

achalasia gastroesophageal reflux disease hiatus hernia obesity disorder opioid abuse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use

Contacts and locations

Locations

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.