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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birgitte Ruhnau, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01317368
First received: March 11, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Postoperative Pain
Drug: Naropine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS pain score at rest, recorded as a Area Under Curve (AUC/24h) [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]

    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) [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]

    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


  • Sedation [ Time Frame: Recorded at 0-24 hours postoperative ] [ Designated as safety issue: No ]

    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 [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Recorded 0-24 postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    This outcome is recorded in and compared between all three groups.


Enrollment: 75
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAP block

TAP block with Ropivacaine

Wound infiltration with Saline

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.

Other Names:
  • Ropivacaine
  • TAP block
  • Wound infiltration
  • Placebo
Active Comparator: Wound infiltration

TAP block with Saline.

Wound infiltration with Ropivacaine.

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 Names:
  • Ropivacaine
  • TAP block
  • Wound infiltration
  • Placebo
Placebo Comparator: Placebo

TAP block with Saline.

Wound infiltration with Saline.

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.

Other Names:
  • Ropivacaine
  • TAP block
  • Wound infiltration
  • Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317368

Locations
Denmark
The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Birgitte Ruhnau, Consultant Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
  More Information

No publications provided

Responsible Party: Birgitte Ruhnau, Consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01317368     History of Changes
Other Study ID Numbers: SM1-AS-2010, 2010-024153-36
Study First Received: March 11, 2011
Last Updated: June 19, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Danish Medicines Agency
Denmark: The Danish Data Protection Agency
Denmark: The Good Clinical Practice (GCP) Unit at Copenhagen University

Keywords provided by Rigshospitalet, Denmark:
Postoperative analgesic treatment
TAP block
Prostatectomy
Double blinded randomized clinical trial

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Analgesics
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014