Regional TAP Block for Bariatric Patients

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

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

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery; Transverse Abdominal Plane Regional Blocks
• Intervention / Treatment: Procedure: Transverse abdominal plane block; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Other Names: TAP; Drug: 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.
No Intervention: No intervention; General anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Karina Gritsenko, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 13-01-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes