Regional TAP Block for Bariatric Patients

NCT ID: NCT04051684

Last Updated: 2019-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Bariatric Surgery Transverse Abdominal Plane Regional Blocks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TAP, Bupivacaine

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.

Group Type EXPERIMENTAL

Transverse abdominal plane block

Intervention Type PROCEDURE

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.

Ropivacaine

Intervention Type DRUG

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.

No intervention

General anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transverse abdominal plane block

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.

Intervention Type PROCEDURE

Ropivacaine

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.

Intervention Type DRUG

Other Intervention Names

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TAP

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Karina Gritsenko

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karina Gritsenko, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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13-01-013

Identifier Type: -

Identifier Source: org_study_id

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