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Australian New Zealand Clinical Trials Registry

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 081697
ACTR Number: ACTRN12607000102471
Trial Status: Registered
Date Submitted: 16/11/2006
Date Registered: 31/01/2007

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Public title: Caudal anaesthesia vs lignocaine gel for TRUS biopsy of the prostate. A randomised controlled trial
ANZCTR registration title: 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.
Secondary ID: 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
Prostate cancer 
Condition category: Condition code:
Cancer Prostate 

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Description of intervention(s) / exposure: 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.
Intervention code:Treatment: drugs 
Comparator / control treatment: Subjects in the control group will have 2% lignocaine gel applied to the ultrasound probe immediately prior to its insertion (usual practice).
Control group: Active

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Primary outcome:Pain as assessed by 100 mm visual analoge scale. 
Timepoint:Measured immediatley prior to and after caudal injection and immediately prior to and after the first TRUS biopsy. Pain scores will be assessed prior to discharge from the recovery room. 
Secondary outcome:Patient and surgeon satisfaction. 
Timepoint:Surgeon satisfaction will be assessed immediately after TRUS biopsy is performed. Patient satisfaction will be assessed prior to their discharge from recovery. 

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Key inclusion criteria: Inclusion: Adult patients undergoing TRUS biopsy of the prostate able to give consent.
Minimum Age: 18 Years
Maximum Age: Not stated
Gender: Males
Healthy volunteers? No
Key exclusion criteria: Allergy to lignocaine, known contraindication to neuraxial blockade (sepsis, abnormal spinal anatomy, bleeding diathesis)

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Sealed opaque envelopes
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Prospective computer generated block randomization
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people assessing the outcomes
Assignment: Parallel
Other design features (specify): assessors
Type of endpoint(s): Efficacy

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Phase
Anticipated or actual date of first participant enrolement: 5/02/2007
Target sample size: 50
Recruitment status: Not yet recruiting

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Funding source:Hospital 
Name:St Vincents Hospital 
Address: 
Country:Australia 
Primary sponsor: Individual
Name: Dr Suzi Nou
Address:
Country:
Secondary sponsor:Individual 
Name:Dr Keng Low 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? No
Ethics Committee name:St Vincent's Hospital, Melbourne. 
Address:Melbourne. 
Country:Australia 
Date submitted/Date which intend to submit to ethics committee: 
Countries of recruitment:Outside Australia 
New Zealand 
Brief summary: Trans-rectal ultrasound (TRUS) guided biopsy of the prostate is a routine method of testing for prostate cancer, which is one of the most common cancers affecting men. The procedure involves passing a probe into the rectum and guiding a needle into the prostate to obtain tissue. Usually 6 to 24 biopsies are taken and the ability to detect cancer improves with increasing biopsies.
Pain relief for this procedure has ranges from nothing or local anaesthetic gel, when performed in the urologist’s room to full general anaesthesia when performed in hospital. Numerous studies have found that injection of local anaesthetic around the prostate improves pain relief and tolerance of the procedure.
Caudal anaesthesia is a common method of providing pain relief. It is almost routinely used in children undergoing genital and lower abdominal surgery such as circumcision and hernia repair. It is also used in adults undergoing perianal surgery such as haemorrhoidectomy.
Caudal anaesthesia involves injecting local anaesthetic into the caudal space. The caudal space is a continuation of the epidural space, a fatty layer around the spinal cord.
This study will compare the pain relief provided by caudal anaesthesia with local anaesthetic gel in men undergoing TRUS guided biopsy of the prostate
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dr Suzi Nou
Address: St Vincent's Hospital Victoria Parade Fitzroy Melbourne VIC 3064
Country: Australia
Tel: +61 3 92882211
Fax: +61 3 92884255
Email: suzi_nou@yahoo.com

Contact person for scientific queries
Name: Dr Suzi Nou
Address: St Vincent's Hospital Victoria Parade Fitzroy Melbourne VIC 3064
Country: Australia
Tel: +61 412 080892
Fax: +61 3 92884255
Email: suzi_nou@yahoo.com

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