The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
NCT ID: NCT01317368
Last Updated: 2012-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2011-03-31
2012-02-29
Brief Summary
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The different treatments the investigators wish to investigate is:
1. Transversus Abdominis Plane (TAP) block.
The TAP block is a rather new method, where a local anaesthetic is deposited between the two inner abdominal muscles. Between these muscles, the nerves that innervates the anterior part of the abdominal wall is situated.
2. Wound infiltration
In this method you deposit a local anaesthetic in the edges of the wound.
3. Placebo
No active local treatment is given.
All patients who wish to participate will be allocated to one of three different treatment groups.
Group 1:
Will receive TAP block with a local anaesthetic and wound infiltration with saline.
Group 2:
Will receive wound infiltration with a local anaesthetic and TAP block with saline.
Group 3:
Will receive TAP block with saline and wound infiltration with saline.
Beside this local treatment all patients will be given systemic Paracetamol (tablet) and Ibuprofen (tablet).
In addition all patients will be given a pump containing morphine. The pump is connected to a button which the patient can activate when they experience pain. This enables the patient to control how much morphine he needs, following the operation.
The hypothesis is that the TAP block is superior in reducing pain and thereby reducing morphine consumption compared to wound infiltration and placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAP block
TAP block with Ropivacaine
Wound infiltration with Saline
Naropine
20 mL of 0,75% Naropin is deposited on each side (40 mL in total) in the TAP.
At the same time 40 mL of saline 0,9% will be deposited subcutaneously as wound infiltration.
Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.
Wound infiltration
TAP block with Saline.
Wound infiltration with Ropivacaine.
Naropine
20 mL Saline 0,9% is deposited on each side (40 mL in total) in the TAP.
At the same time 40 mL Ropivacaine 0,75% will be deposited subcutaneously as wound infiltration.
Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.
Placebo
TAP block with Saline.
Wound infiltration with Saline.
Placebo
20 mL 0,9% Saline is deposited on each side (40 mL in total) in the TAP.
At the same time 40 mL Saline 0,9% will be given as wound infiltration.
Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.
Interventions
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Naropine
20 mL of 0,75% Naropin is deposited on each side (40 mL in total) in the TAP.
At the same time 40 mL of saline 0,9% will be deposited subcutaneously as wound infiltration.
Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.
Naropine
20 mL Saline 0,9% is deposited on each side (40 mL in total) in the TAP.
At the same time 40 mL Ropivacaine 0,75% will be deposited subcutaneously as wound infiltration.
Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.
Placebo
20 mL 0,9% Saline is deposited on each side (40 mL in total) in the TAP.
At the same time 40 mL Saline 0,9% will be given as wound infiltration.
Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have given their informed consent and have fully understood the nature and limitations of the study
* Patient who is planned for radical prostatectomy
Exclusion Criteria
* Is not able to speak and understand danish
* Allergy towards the drugs which is used in the study
* Daily use of strong opioids
* Infection at the injection area
18 Years
80 Years
MALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Birgitte Ruhnau
Consultant
Principal Investigators
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Birgitte Ruhnau, Consultant
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Locations
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The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Copenhagen Ø, , Denmark
Countries
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Other Identifiers
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2010-024153-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SM1-AS-2010
Identifier Type: -
Identifier Source: org_study_id
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