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

NCT01317368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-06-20

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Naropine

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.

DRUG

Naropine

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Birgitte Ruhnau, Consultant · Department of Anaesthesiology, Abdominal Centre, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01317368 on ClinicalTrials.gov