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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000102471
Ethics application status
Not yet submitted
Date submitted
16/11/2006
Date registered
31/01/2007
Date last updated
31/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Caudal anaesthesia vs lignocaine gel for TRUS biopsy of the prostate. A randomised controlled trial
Scientific 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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 1596 0
Condition category
Condition code
Cancer 1699 1699 0 0
Prostate

Intervention/exposure
Study type
Interventional
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 [1] 1451 0
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

Outcomes
Primary outcome [1] 2356 0
Pain as assessed by 100 mm visual analoge scale.
Timepoint [1] 2356 0
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 [1] 4111 0
Patient and surgeon satisfaction.
Timepoint [1] 4111 0
Surgeon satisfaction will be assessed immediately after TRUS biopsy is performed. Patient satisfaction will be assessed prior to their discharge from recovery.

Eligibility
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
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to lignocaine, known contraindication to neuraxial blockade (sepsis, abnormal spinal anatomy, bleeding diathesis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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?



Intervention assignment
Parallel
Other design features
assessors
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 419 0
New Zealand
State/province [1] 419 0

Funding & Sponsors
Funding source category [1] 1842 0
Hospital
Name [1] 1842 0
St Vincents Hospital
Address [1] 1842 0
Country [1] 1842 0
Australia
Primary sponsor type
Individual
Name
Dr Suzi Nou
Address
Country
Secondary sponsor category [1] 1660 0
Individual
Name [1] 1660 0
Dr Keng Low
Address [1] 1660 0
Country [1] 1660 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3444 0
St Vincent's Hospital, Melbourne.
Ethics committee address [1] 3444 0
Melbourne.
Ethics committee country [1] 3444 0
Australia
Date submitted for ethics approval [1] 3444 0
Approval date [1] 3444 0
Ethics approval number [1] 3444 0

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27385 0
Address 27385 0
Country 27385 0
Phone 27385 0
Fax 27385 0
Email 27385 0
Contact person for public queries
Name 10640 0
Dr Suzi Nou
Address 10640 0
St Vincent's Hospital
Victoria Parade
Fitzroy Melbourne VIC 3064
Country 10640 0
Australia
Phone 10640 0
+61 3 92882211
Fax 10640 0
+61 3 92884255
Email 10640 0
suzi_nou@yahoo.com
Contact person for scientific queries
Name 1568 0
Dr Suzi Nou
Address 1568 0
St Vincent's Hospital
Victoria Parade
Fitzroy Melbourne VIC 3064
Country 1568 0
Australia
Phone 1568 0
+61 412 080892
Fax 1568 0
+61 3 92884255
Email 1568 0
suzi_nou@yahoo.com

No information has been provided regarding IPD availability
Summary results
No Results