Regional TAP Block for Bariatric Patients

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051684
• Other study ID #: 13-01-013
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Est. completion date: May 2013

Study information

• Verified date: November 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Transverse Abdominal Plane Regional Blocks

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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