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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 is currently recruiting participants.
Verified April 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01075087
First received: February 23, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  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 30 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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 24h total opioid consumption [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
    24h total opioid consumption


Secondary Outcome Measures:
  • Intraoperative: opioid consumption [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Intraoperative: opioid consumption


Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Primary Completion Date: March 2014 (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 30 cc of 0.5% ropivacaine on each side.
 Drug: (study group) will receive a bilateral TAP block using 30 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 30 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075087

Contacts
Contact: Gildasio DeOliveira, MD 312-926-8373 gildasiojunior@hotmail.com

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Gildasio DeOliveira, M.D     312-926-8373        
Principal Investigator: Gildasio De Oliveira, MD            
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
Last Updated: April 8, 2013
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 June 13, 2013