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

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ClinicalTrials.gov Identifier: NCT01308554
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Funch-Jensen, Peter, M.D., D.M.Sc.

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Obesity Surgery Neuromuscular Inhibition Drug: Placebo: sterile normal saline Drug: Marcaine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.
Study Start Date : February 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 24h morphine consumption [ Time Frame: 24h after the block is given ]

Secondary Outcome Measures :
  1. 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. ]
    none = 0; mild = 1; moderate = 2; severe = 3

  2. Measurement of lung function (FEV1 and FVC) [ Time Frame: Before surgery and 24h after. ]
  3. 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. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308554


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

Responsible Party: Funch-Jensen, Peter, M.D., D.M.Sc.
ClinicalTrials.gov Identifier: NCT01308554     History of Changes
Other Study ID Numbers: TAP1
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents