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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01075087
First received: February 23, 2010
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Pain
Obesity
Surgery
Drug: Placebo
Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of Recovery 40 Score [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
    Quality of Recovery 40 Score at 24 hours postoperative.


Secondary Outcome Measures:
  • 24 Hour Total Opioid Consumption. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    24 Hour total opioid consumption translated into IV morphine equivalents.


Enrollment: 19
Study Start Date: March 2010
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01075087

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio DeOliveira, MD Northwestern University
  More Information

Publications:

Responsible Party: Gildasio De Oliveira, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01075087     History of Changes
Other Study ID Numbers: STU00023482
Study First Received: February 23, 2010
Results First Received: May 23, 2014
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
TAP Block
Pain
Obesity
Surgery
Laparoscopic Banding

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014