Opioid UsePhase 2/3NCT04655339
Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids
A Phase 2/3 study testing Bilateral abdominal Lap-TAP in people with Opioid Use, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- Bilateral abdominal Lap-TAP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 3 Sep 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric bypass \& sleeve gastrectomy, duodenal switch and minimally invasive elective anti-reflux foregut surgeries such as - hiatal hernia repair, fundoplication and Heller myotomy.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use
- Being tested
- Bilateral abdominal Lap-TAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral abdominal Lap-TAPDrug
Subjects will have Liposomal Bupivacaine (Exparel®) or the control injected into the transversus abdominis plane bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bilateral abdominal Lap-TAP |
| Group-3 | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid dosage requested
opioid dosage requested post-TAP block
Measured: 30days
Secondary outcomes (3)
visual analog scores (VAS)
Measured: 30days
length of stay
Measured: 30days
anti-emetic dosage
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start24 Jan 2020
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Why it stopped: Study was not started due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655339
- Sponsor's protocol ID
- 019-428
- Status last verified
- Jan 2026
- First submitted
- 30 Nov 2020
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids Following Bariatric and Minimally Invasive Foregut Surgery
- ClinicalTrials.gov ID
- NCT04655339
- Acronym / sponsor ID
- 019-428
- Conditions
- Opioid Use
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not started due to COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-1 | Experimental | Drug: Bilateral abdominal Lap-TAPBilateral 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 | Experimental | Drug: Bilateral abdominal Lap-TAPBilateral 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-3 | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gastric bypass \& sleeve gastrectomy, duodenal switch and minimally invasive elective anti-reflux foregut surgeries such as - hiatal hernia repair, fundoplication and Heller myotomy.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral abdominal Lap-TAPSubjects will have Liposomal Bupivacaine (Exparel®) or the control injected into the transversus abdominis plane bilaterally. | Drug | Group-1, Group-2 |
Primary outcome
opioid dosage requested
Time frame: 30days
opioid dosage requested post-TAP block
3 secondary outcomes
visual analog scores (VAS)
Time frame: 30days
length of stay
Time frame: 30days
anti-emetic dosage
Time frame: 30days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bilateral abdominal Lap-TAP in people with Opioid Use, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid dosage requested (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.