Regional TAP Block for Bariatric Patients

Study Overview
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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

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

Conditions
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Bariatric Surgery, Transverse Abdominal Plane Regional Blocks

Intervention / Treatment
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* Procedure: Transverse abdominal plane block
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP, Bupivacaine<br>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. | Procedure: Transverse abdominal plane block<br>* 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.<br>* Other names: TAP;Drug: Ropivacaine<br>* 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.<br>|
| No Intervention: No intervention<br>General anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Opioid Usage | The amounts of opioids used by the patient will be collected by a person blinded to the allocation group | 24 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | Up to 5 hours |