The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

May 23, 2014 updated by: Gildasio De Oliveira, Northwestern University

TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-65 years
  • BMI >35 Kg/m2
  • Surgery: laparoscopic gastric bypass surgery
  • ASA status: I, II and III
  • Fluent in English

Exclusion Criteria:

  • History of allergy to local anesthetics
  • Chronic opioid use
  • Pregnant patients
  • Patients who remained intubated after surgery

Drop-out criteria:

Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
(control group) will receive sterile normal saline in the block
Drug: Placebo
Bilateral TAP block using sterile normal saline.
Active Comparator: Active comparator
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery 40 Score
Time Frame: 24 hours post operatively
Quality of Recovery 40 Score at 24 hours postoperative.
24 hours post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 Hour Total Opioid Consumption.
Time Frame: 24 hours
24 Hour total opioid consumption translated into IV morphine equivalents.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Gildasio DeOliveira, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00023482

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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