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

NCT01308554 | Completed Phase 4

• 1 other identifier: TAP1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Obesity; Surgery; Neuromuscular Inhibition

Keywords

TAP block; Pain; Obesity; Surgery; Laparoscopic gastric bypass

Outcome Measures

Primary Outcomes (1)

• 24h morphine consumption

  24h after the block is given

Secondary Outcomes (3)

• Post operative nausea score

  Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.

• Measurement of lung function (FEV1 and FVC)

  Before surgery and 24h after.

• The Verbal Analogue Scale (VAS) scores at rest and on moving

  Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.

Study Arms (2)

Sterile normal saline

PLACEBO COMPARATOR

Control group will receive sterile normal saline in the block

Drug: Placebo: sterile normal saline

Marcaine

ACTIVE COMPARATOR

Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side.

Drug: Marcaine

Interventions

Placebo: sterile normal saline DRUG

Bilateral TAP block using 20 ml of normal sterile saline per block.

Also known as: Saline water, Saline solution, Sodium chloride, NaCl, Salt

Sterile normal saline

Marcaine DRUG

Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.

Also known as: Bupivacaine

Marcaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Funch-Jensen, Peter, M.D., D.M.Sc.: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Privathospitalet Hamlet Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pain; Obesity

Interventions

Saline Waters; Saline Solution; Sodium Chloride; Salts; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Environment; Ecological and Environmental Phenomena; Biological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Peter Funch-Jensen, D.M.Sc.

  Privathospital Hamlet Aarhus, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

DK (1)