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

Rigshospitalet

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Naropine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01317368

2010-024153-36 (EudraCT Number)

SM1-AS-2010

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

TAP block

Active Comparator group

Description:

TAP block with Ropivacaine Wound infiltration with Saline

Treatment:

Drug: Naropine

Drug: Naropine

Wound infiltration

Active Comparator group

Description:

TAP block with Saline. Wound infiltration with Ropivacaine.

Treatment:

Drug: Naropine

Drug: Naropine

Placebo

Placebo Comparator group

Description:

TAP block with Saline. Wound infiltration with Saline.

Treatment:

Other: Placebo