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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317368
• Other study ID #: SM1-AS-2010
• Secondary ID: 2010-024153-36
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: June 19, 2012
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Danish Medicines AgencyDenmark: The Danish Data Protection AgencyDenmark: The Good Clinical Practice (GCP) Unit at Copenhagen University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Cumulated morphine consumption	This outcome is recorded in and compared between all three groups.	24 hours postoperative	No