Bariatric SurgeryPhase 1/2NCT04051684

Regional TAP Block for Bariatric Patients

A Phase 1/2 study testing Transverse abdominal plane block and Ropivacaine in people with Bariatric Surgery and Transverse Abdominal Plane Regional Blocks, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI >35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Bariatric Surgery, Transverse Abdominal Plane Regional Blocks
What is being tested?: Transverse abdominal plane block and Ropivacaine
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Apr 2013to May 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient must be 18 years of age or older and able to provide his or her own consent.
The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass.
The patient must be surgically and medically accepted for the procedure
Good functional status, ability to perform activities of daily living
The patients BMI > 35, no upper limit
Signed study specific informed consent prior to enrollment

Who cannot join

Patients with an allergy to local anesthetics
Patients diagnosed with peripheral neuropathies including diabetes mellitus.
Patients with BMI <35
Patients with significant coronary artery disease
Patient refusal of block procedure.
Patients with chronic pain
Patients on pre-operative maintenance narcotics
American Society of Anesthesiologist classification system 4 (ASA 4) patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Transverse Abdominal Plane Blocks for Bariatric Surgery Patients: A Single Blinded Randomized Controlled Study

Conditions: Bariatric Surgery, Transverse Abdominal Plane Regional Blocks
Being tested: Transverse abdominal plane block, Ropivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transverse abdominal plane blockProcedure or surgery
Also called TAP
Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
RopivacaineDrug
Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.

Study groups in NCT04051684
Study group	Role	What they receive
TAP, Bupivacaine	Experimental	This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Receives: Procedure: Transverse abdominal plane block; Drug: Ropivacaine
No intervention	No intervention	General anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Post Operative Opioid Usage
The amounts of opioids used by the patient will be collected by a person blinded to the allocation group
Measured: 24 hour after surgery

Secondary outcomes (3)

Pain Score Assessed With Visual Analog Score (VAS)
Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU)
Measured: 30 minutes within arrival to PACU
Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review
The number of participants experiencing nausea will be assessed by chart review
Measured: Up to 5 hours
Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review
The number of participants experiencing vomiting will be assessed by chart review
Measured: Up to 5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013May 2013

First posted9 Aug 2019
Study startApr 2013
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04051684
Sponsor's protocol ID: 13-01-013
Status last verified: Nov 2019
First submitted: 19 Nov 2018
Last updated: 3 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transverse Abdominal Plane Blocks for Bariatric Surgery Patients: A Single Blinded Randomized Controlled Study
ClinicalTrials.gov ID: NCT04051684
Acronym / sponsor ID: 13-01-013
Conditions: Bariatric Surgery, Transverse Abdominal Plane Regional Blocks
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: Apr 2013 (actual)
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 Aug 2019 (actual)
Results: Posted 3 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TAP, Bupivacaine	Experimental	Procedure: Transverse abdominal plane block, Drug: RopivacaineThis group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No intervention	No intervention	–General anesthesia

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The patient must be 18 years of age or older and able to provide his or her own consent.
The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass.
The patient must be surgically and medically accepted for the procedure
Good functional status, ability to perform activities of daily living
The patients BMI > 35, no upper limit

Key exclusion criteria (8 listed)

Patients with an allergy to local anesthetics
Patients diagnosed with peripheral neuropathies including diabetes mellitus.
Patients with BMI <35
Patients with significant coronary artery disease
Patient refusal of block procedure.

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
Transverse abdominal plane blockAlso: TAPRegional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.	Procedure or surgery	TAP, Bupivacaine
RopivacaineRegional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.	Drug	TAP, Bupivacaine

Primary outcome

Post Operative Opioid Usage
Time frame: 24 hour after surgery
The amounts of opioids used by the patient will be collected by a person blinded to the allocation group

3 secondary outcomes

Pain Score Assessed With Visual Analog Score (VAS)
Time frame: 30 minutes within arrival to PACU
Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review
Time frame: Up to 5 hours
Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review
Time frame: Up to 5 hours

Results and safety

Results posted to the registry on 3 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAP, Bupivacaine	12	12
No Intervention	11	11

Primary outcome: Post Operative Opioid Usage

Time frame: 24 hour after surgery. Median (Inter-Quartile Range). Unit: morphine equivalent

Measure	TAP, Bupivacaine n = 12	No Intervention n = 11
Value	2.25 (2.25 to 4)	4 (2 to 4)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAP, Bupivacaine	0 of 12 (0%)	0 of 12 (0%)	0 of 12
No Intervention	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruiting
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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.

Karina Gritsenko, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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: finished, as of the sponsor's last update on 3 Dec 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post Operative Opioid Usage (time frame: 24 hour after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04051684.

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 3 Dec 2019.