The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Versus Wound Infiltration Versus Placebo Following Open Radical Prostatectomy, a Double Blinded, Randomized Clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Naropine
* Drug: Naropine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block<br>TAP block with Ropivacaine Wound infiltration with Saline | Drug: Naropine<br>* 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.<br>* Other names: Placebo;|
| Active Comparator: Wound infiltration<br>TAP block with Saline. Wound infiltration with Ropivacaine. | Drug: Naropine<br>* 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.<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>TAP block with Saline. Wound infiltration with Saline. | Other: Placebo<br>* 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.<br>* Other names: Wound infiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 4 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Recorded 0-24 hours postoperative | 
| 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. | Recorded 0-24 hours postoperative | 
| 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 | Recorded 0-24 hours postoperative | 
| 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. | Recorded at 0-24 hours postoperative | 
| 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 | Recorded 0-24 hours postoperative | 
| 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 | Recorded 0-24 postoperative | 
| Cumulated morphine consumption | This outcome is recorded in and compared between all three groups. | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative analgesic treatment, TAP block, Prostatectomy, Double blinded randomized clinical trial