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Completed

NCT Number: NCT04051684

Regional TAP Block for Bariatric Patients

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

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Key information

Conditions

Bariatric Surgery Transverse Abdominal Plane Regional Blocks

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transverse abdominal plane block

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.

Other names: TAP

Ropivacaine

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.

Primary outcomes

  1. Post Operative Opioid Usage

    Time frame: 24 hour after surgery

    The amounts of opioids used by the patient will be collected by a person blinded to the allocation group

Secondary outcomes

  1. Pain Score Assessed With Visual Analog Score (VAS)

    Time frame: 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)

  2. Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review

    Time frame: Up to 5 hours

    The number of participants experiencing nausea will be assessed by chart review

  3. Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review

    Time frame: Up to 5 hours

    The number of participants experiencing vomiting will be assessed by chart review

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2019
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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