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

The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Versus Wound Infiltration Versus Placebo Following Open Radical Prostatectomy, a Double Blinded, Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Naropine; Drug: Naropine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen Ø, Denmark, 2100
    • The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; Ropivacaine; TAP block; Wound infiltration; 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: Placebo; Ropivacaine; TAP block; Wound infiltration
ACTIVE_COMPARATOR: Wound infiltration; TAP block with Saline. Wound infiltration with Ropivacaine.	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: Placebo; Ropivacaine; TAP block; Wound infiltration; 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: Placebo; Ropivacaine; TAP block; Wound infiltration
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	4 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)	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.	Recorded 0-24 hours postoperative
VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)	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.	Recorded 0-24 hours postoperative
Nausea	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	Recorded 0-24 hours postoperative
Sedation	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.	Recorded at 0-24 hours postoperative
Vomiting	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	Recorded 0-24 hours postoperative
On-going morphine consumption	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	Recorded 0-24 postoperative
Cumulated morphine consumption	This outcome is recorded in and compared between all three groups.	24 hours postoperative

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Birgitte Ruhnau, Consultant, Department of Anaesthesiology, Abdominal Centre, Rigshospitalet

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (ESTIMATE): March 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Prostatectomy; TAP block; Postoperative analgesic treatment; Double blinded randomized clinical trial
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SM1-AS-2010; 2010-024153-36 (EUDRACT_NUMBER)