Pain Relieving Efficacy of TAP Block in Patients After Laparoscopic Gastric Bypass.

This study has been completed.
Medtronic - MITG
Information provided by (Responsible Party):
Funch-Jensen, Peter, M.D., D.M.Sc. Identifier:
First received: March 2, 2011
Last updated: March 25, 2014
Last verified: March 2014
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
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:

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 ]

Enrollment: 80
Study Start Date: February 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sterile normal saline
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 Name: Bupivacaine

  Show Detailed Description


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01308554

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

Responsible Party: Funch-Jensen, Peter, M.D., D.M.Sc. Identifier: NCT01308554     History of Changes
Other Study ID Numbers: TAP1 
Study First Received: March 2, 2011
Last Updated: March 25, 2014
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
Laparoscopic gastric bypass

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on April 27, 2016