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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12607000102471 |
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Date of registration:
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31/01/2007 |
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Primary sponsor: |
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Public title:
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Caudal anaesthesia vs lignocaine gel for TRUS biopsy of the prostate. A randomised controlled trial
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Scientific title:
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A randomised study to investigate the effects of caudal lignocaine versus topical lignocaine on VAS pain scores in men undergoing trans-rectal ultrasound guided biopsy of the prostate for the detection of prostate cancer. |
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Date of first enrolment:
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5/02/2007 |
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Target sample size:
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50 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12607000102471.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Countries of recruitment
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New Zealand
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Contacts
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Name:
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Dr Suzi Nou |
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Address:
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St Vincent''s Hospital
Victoria Parade
Fitzroy Melbourne VIC 3064, Australia
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Telephone:
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+61 3 92882211 |
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Email:
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suzi_nou@yahoo.com |
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Affiliation:
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Name:
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Dr Suzi Nou |
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Address:
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St Vincent''s Hospital
Victoria Parade
Fitzroy Melbourne VIC 3064, Australia
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Telephone:
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+61 412 080892 |
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Email:
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suzi_nou@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion: Adult patients undergoing TRUS biopsy of the prostate able to give consent.
Exclusion criteria: Allergy to lignocaine, known contraindication to neuraxial blockade (sepsis, abnormal spinal anatomy, bleeding diathesis)
Age minimum:
18 Years
Age maximum:
0 Not stated
Gender:
Males
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Health Condition(s) or Problem(s) studied
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Prostate cancer
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Intervention(s)
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A single injection of 4mg / kg (ideal body weight) of 2% lignocaine (to a maximum of 400 mg) into the caudal epidural space prior to TRUS biopsy. A TRUS biopsy is usually completed within 15 - 20 minutes. Following the TRUS biopsy, subjects are cared for in the recovery room for a minimum of 30 minutes.
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Primary Outcome(s)
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Pain as assessed by 100 mm visual analoge scale.
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Secondary Outcome(s)
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Patient and surgeon satisfaction.
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Source(s) of Monetary Support
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St Vincents Hospital
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