The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Naropine
Naropine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative analgesic treatment, TAP block, Prostatectomy, Double blinded randomized clinical trial
Eligibility Criteria
Inclusion Criteria:
- BMI > 18 and < 35
- 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:
- Not able to cooperate to complete the study
- 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
Sites / Locations
- The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
TAP block
Wound infiltration
Placebo
Arm Description
TAP block with Ropivacaine Wound infiltration with Saline
TAP block with Saline. Wound infiltration with Ropivacaine.
TAP block with Saline. Wound infiltration with Saline.
Outcomes
Primary Outcome Measures
A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group.
Secondary Outcome Measures
VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)
This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative, while the patient is supine in his bed.
This outcome is recorded in and compared between all three groups.
VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)
This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative. This outcome is recorded in and compared between all three groups.
Nausea
On a scale ranging none-mild-moderate-severe at 1, 2, 4, 6, 8, 20, 24 hours postoperative.
This outcome is recorded in and compared between all three groups
Sedation
On a scale ranging none-mild-moderate-severe this outcome is assessed at 1, 2, 4, 6, 8, 20 and 24 hours postoperative.
This outcome is recorded in and compared between all three groups.
Vomiting
The number of times the patient produces more than 10 mL of vomit. Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded in and compared between all three groups
On-going morphine consumption
Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded and compared between all three groups
Cumulated morphine consumption
This outcome is recorded in and compared between all three groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01317368
Brief Title
The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
Official Title
The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Versus Wound Infiltration Versus Placebo Following Open Radical Prostatectomy, a Double Blinded, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is conducted to evaluate different analgesic treatments effect following operation where the prostate gland is surgically removed.
The different treatments the investigators wish to investigate is:
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.
Wound infiltration
In this method you deposit a local anaesthetic in the edges of the wound.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative analgesic treatment, TAP block, Prostatectomy, Double blinded randomized clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAP block
Arm Type
Active Comparator
Arm Description
TAP block with Ropivacaine
Wound infiltration with Saline
Arm Title
Wound infiltration
Arm Type
Active Comparator
Arm Description
TAP block with Saline.
Wound infiltration with Ropivacaine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TAP block with Saline.
Wound infiltration with Saline.
Intervention Type
Drug
Intervention Name(s)
Naropine
Other Intervention Name(s)
Ropivacaine, TAP block, Wound infiltration, Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Naropine
Other Intervention Name(s)
Ropivacaine, TAP block, Wound infiltration, Placebo
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Ropivacaine, TAP block, Wound infiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group.
Time Frame
4 hours postoperative
Secondary Outcome Measure Information:
Title
VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)
Description
This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative, while the patient is supine in his bed.
This outcome is recorded in and compared between all three groups.
Time Frame
Recorded 0-24 hours postoperative
Title
VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)
Description
This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative. This outcome is recorded in and compared between all three groups.
Time Frame
Recorded 0-24 hours postoperative
Title
Nausea
Description
On a scale ranging none-mild-moderate-severe at 1, 2, 4, 6, 8, 20, 24 hours postoperative.
This outcome is recorded in and compared between all three groups
Time Frame
Recorded 0-24 hours postoperative
Title
Sedation
Description
On a scale ranging none-mild-moderate-severe this outcome is assessed at 1, 2, 4, 6, 8, 20 and 24 hours postoperative.
This outcome is recorded in and compared between all three groups.
Time Frame
Recorded at 0-24 hours postoperative
Title
Vomiting
Description
The number of times the patient produces more than 10 mL of vomit. Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded in and compared between all three groups
Time Frame
Recorded 0-24 hours postoperative
Title
On-going morphine consumption
Description
Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded and compared between all three groups
Time Frame
Recorded 0-24 postoperative
Title
Cumulated morphine consumption
Description
This outcome is recorded in and compared between all three groups.
Time Frame
24 hours postoperative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 18 and < 35
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:
Not able to cooperate to complete the study
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte Ruhnau, Consultant
Organizational Affiliation
Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
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