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Pain Relieving Efficacy of Subcostal Transversus Abdominis Plane (TAP) Block in Patients After Laparoscopic Gastric Bypass.

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Funch-Jensen, Peter, M.D., D.M.Sc.
ClinicalTrials.gov Identifier:
NCT01308554
First received: March 2, 2011
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is to determine whether injection of bupivacaine into the TAP is effective in the treatment of post operative pain after laparoscopic gastric bypass


Condition Intervention Phase
Pain
Obesity
Surgery
Neuromuscular Inhibition
 Drug: Placebo: sterile normal saline
Drug: Marcaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Funch-Jensen, Peter, M.D., D.M.Sc.:

Primary Outcome Measures:
  • 24h morphine consumption [ Time Frame: 24h after the block is given ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post operative nausea score [ Time Frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks. ] [ Designated as safety issue: No ]
    none = 0; mild = 1; moderate = 2; severe = 3

  • Measurement of lung function (FEV1 and FVC) [ Time Frame: Before surgery and 24h after. ] [ Designated as safety issue: No ]
  • The Verbal Analogue Scale (VAS) scores at rest and on moving [ Time Frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 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: sterile normal saline
Bilateral TAP block using 20 ml of normal sterile saline per block.
Other Names:
  • Saline water
  • Saline solution
  • Sodium chloride
  • NaCl
  • Salt
Active Comparator: Marcaine
Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side.
 Drug: Marcaine
Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.
Other Names:
  • Marcaine
  • Bupivacaine

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • All patients aged over 18 years who are scheduled for elective gastric bypass (incisions with the lower end of the incision at or above thoracic T 10 dermatome)

Exclusion Criteria:

  • Lack of consent including from those patients who lack mental capacity to give informed consent
  • Patients with history of drug allergy to bupivacaine
  • Patients with history of chronic pain conditions: defined as patients with history of pain for above 3 months and who consume regular analgesics for their chronic pain
  • American Society of Anesthesiologists (ASA) Class 4 and 5
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308554

Locations
Denmark
Privathospitalet Hamlet Aarhus
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Funch-Jensen, Peter, M.D., D.M.Sc.
Covidien
Investigators
Principal Investigator: Peter Funch-Jensen, D.M.Sc. Privathospital Hamlet Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Funch-Jensen, Peter, M.D., D.M.Sc.
ClinicalTrials.gov Identifier: NCT01308554     History of Changes
Other Study ID Numbers: TAP1
Study First Received: March 2, 2011
Last Updated: November 21, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Funch-Jensen, Peter, M.D., D.M.Sc.:
TAP block
Pain
Obesity
Surgery
Laparoscopic gastric bypass

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bupivacaine
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 May 16, 2013