Regional TAP Block for Bariatric Patients

Phase 1

Completed

• Conditions: Bariatric Surgery; Transverse Abdominal Plane Regional Blocks
• Interventions: Procedure: Transverse abdominal plane block; Drug: Ropivacaine

• Registration Number: NCT04051684
• Lead Sponsor: Montefiore Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Results First Submitted: 2019-10-21
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-13
• Last Update Submitted: 2019-11-13
• Results First Posted: 2019-12-03
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP, Bupivacaine	Transverse abdominal plane block	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.
TAP, Bupivacaine	Ropivacaine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review	Up to 5 hours	The number of participants experiencing nausea will be assessed by chart review
Pain Score Assessed With Visual Analog Score (VAS)	30 minutes within arrival to PACU	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)
Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review	Up to 5 hours	The number of participants experiencing vomiting will be assessed by chart review

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States