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Completed

NCT Number: NCT01317368

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet

Copenhagen Ø, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naropine

Drug

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.

Other names: Ropivacaine, TAP block, Wound infiltration, Placebo

Placebo

Other

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.

Other names: Ropivacaine, TAP block, Wound infiltration

Primary outcomes

  1. 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.

    Time frame: 4 hours postoperative

Secondary outcomes

  1. VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)

    Time frame: 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.

  2. VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)

    Time frame: 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.

  3. Nausea

    Time frame: 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 groups

  4. Sedation

    Time frame: 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.

  5. Vomiting

    Time frame: 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

  6. On-going morphine consumption

    Time frame: 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

  7. Cumulated morphine consumption

    Time frame: 24 hours postoperative

    This outcome is recorded in and compared between all three groups.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 17, 2011
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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