Clinical trial NCT01317368: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative analgesic treatment
TAP block
Prostatectomy
Double blinded randomized clinical trial
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 4 hours postoperative
Secondary outcomes:
measure: VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)
timeFrame: Recorded 0-24 hours postoperative
measure: VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)
timeFrame: Recorded 0-24 hours postoperative
measure: Nausea
timeFrame: Recorded 0-24 hours postoperative
measure: Sedation
timeFrame: Recorded at 0-24 hours postoperative
measure: Vomiting
timeFrame: Recorded 0-24 hours postoperative
measure: On-going morphine consumption
timeFrame: Recorded 0-24 postoperative
measure: Cumulated morphine consumption
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Copenhagen Ø
country: Denmark
facility: The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Study officials:
affiliation: Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
name: Birgitte Ruhnau, Consultant
role: PRINCIPAL_INVESTIGATOR
References: