The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
- Conditions
- Postoperative Pain
- Interventions
- Drug: NaropineOther: Placebo
- Registration Number
- NCT01317368
- Lead Sponsor
- Rigshospitalet, Denmark
- 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:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAP block Naropine TAP block with Ropivacaine Wound infiltration with Saline Wound infiltration Naropine TAP block with Saline. Wound infiltration with Ropivacaine. Placebo Placebo TAP block with Saline. Wound infiltration with Saline.
- Primary Outcome Measures
Name Time Method 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
Name Time Method VAS pain score at rest, recorded as a Area Under Curve (AUC/24h) Recorded 0-24 hours postoperative 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) Recorded 0-24 hours postoperative 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 Recorded 0-24 hours postoperative 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 groupsSedation Recorded at 0-24 hours postoperative 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 Recorded 0-24 hours postoperative 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 0-24 postoperative 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 24 hours postoperative This outcome is recorded in and compared between all three groups.
Trial Locations
- Locations (1)
The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
🇩🇰Copenhagen Ø, Denmark