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Trial registered on ANZCTR


Registration number
ACTRN12616001310459
Ethics application status
Approved
Date submitted
14/09/2016
Date registered
19/09/2016
Date last updated
2/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Local anaesthesia for transperineal prostate biopsy – a randomised control trial
Scientific title
Effect of local anaesthesia for transperineal prostate biopsy on post-procedure pain scores – a randomised control trial
Secondary ID [1] 290156 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate biopsy 300277 0
Condition category
Condition code
Cancer 300145 300145 0 0
Prostate
Anaesthesiology 300156 300156 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Prospective, single blinded, randomised control trial
2. The population to be studied is men undergoing transperineal prostate biopsy under general anaesthesia.
3. This will be a multi-centre national study.
4. Men will be randomised into 2 groups, a treatment group and a control group.
5. All patients undergoing the procedure are put under general anaesthesia.
6. Men in the treatment group will receive infiltration of local anaesthetic (20mls of 0.5% bupivacaine, once only) into the perineal skin by the treating surgeon at the end of the procedure but prior to the patient being woken from general anaesthesia.
7. Men in the control group will receive no intervention
8. The design of this study (RCT) will enable data collection and analysis to determine whether or not infiltration of local anaesthetic at the time of transperineal prostate biopsy is effective. That is, does it reliably reduce pain scores (VAS and short McGill pain questionnaire) and are the results statistically significant.
Intervention code [1] 295910 0
Treatment: Drugs
Intervention code [2] 295918 0
Prevention
Comparator / control treatment
Patients in the control group will receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 299628 0
Postoperative pain assessed via VAS and Short McGill Pain Questionnaires
Timepoint [1] 299628 0
Primary timepoint: Pain questionnaire to be filled out 30 minutes post procedure in the recovery bay
Secondary outcome [1] 327712 0
Complications post procedure such as urinary retention, re-admission, post-operative infection (perineum or prostate). These outcomes will be assessed via review of patient medical records
Timepoint [1] 327712 0
Within 30 days of procedure

Eligibility
Key inclusion criteria
Men who are undergoing transperineal prostate biopsy will be included in this study
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be considered ineligible if there is a contraindication to infiltration of local anaesthetic (e.g. allergy or previous adverse drug reaction) or they are unable to give informed consent.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations (80% and significance level of 0.05) reveal that at least 75 participants in each arm of the study will be sufficient to demonstrate a statistically significant difference of 1 point on VAS and short mcgill pain questionnaires.

Statistical analysis will be performed with T-test for comparing the means of the Short McGill and VAS pain scores.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/09/2016
Date of last participant enrolment
Anticipated
1/01/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
155
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6663 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 6664 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 14289 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 14290 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 294522 0
Hospital
Name [1] 294522 0
Austin Hospital Urology Department
Country [1] 294522 0
Australia
Primary sponsor type
Individual
Name
Professor Damien Bolton
Address
Austin Health
145 Studley road, Heidelberg, Victoria, 3084

Warringal Private Hospital
216 Burgundy St, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 293385 0
Hospital
Name [1] 293385 0
Austin Health
Address [1] 293385 0
145 Studley road, Heidelberg, Victoria, 3084
Country [1] 293385 0
Australia
Secondary sponsor category [2] 293395 0
Hospital
Name [2] 293395 0
Warringal Private Hospital
Address [2] 293395 0
216 Burgundy St, Heidelberg, Victoria, 3084
Country [2] 293395 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295955 0
Austin Health Ethics Committee
Ethics committee address [1] 295955 0
Research Ethics
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 295955 0
Australia
Date submitted for ethics approval [1] 295955 0
11/01/2016
Approval date [1] 295955 0
14/01/2016
Ethics approval number [1] 295955 0
HREC/15/Austin/345

Summary
Brief summary
This study aims to determine whether the infiltration of local anaesthetic following transperineal prostate biopsy significantly reduces pain scores as determined by VAS and short McGill pain questionnaire.

Who is it for?
You may be eligible to join this study if you are a male aged 50 years or above and are undergoing transperineal prostate biopsy.

Study details
Men will be allocated into 2 groups by chance, a treatment group and a control group. Men in the treatment group will receive infiltration of local anaesthetic (20mls of 0.5% bupivacaine) into the perineal skin after prostate biopsy. Men in the control group will receive no intervention. Data to be collected will be VAS and short McGill pain questionnaire forms 30 minutes following the procedure (to be filled out by the patient).
The design of this study (RCT) will enable data collection and analysis to determine whether or not infiltration of local anaesthetic at the time of transperineal prostate biopsy is effective. That is, does it reliably reduce pain scores (VAS and short McGill pain questionnaire) and are the results statistically significant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69058 0
A/Prof Nathan Lawrentschuk
Address 69058 0
5/210 Burgundy street, heidelberg, Victoria, 3084
Department of Surgery, Austin Health
Country 69058 0
Australia
Phone 69058 0
+61 3 9455 3363
Fax 69058 0
Email 69058 0
[email protected]
Contact person for public queries
Name 69059 0
Dr Shannon McGrath
Address 69059 0
Austin Health Urology Department
Level 8 Harold Stokes Building,
Austin Hospital,
145 Studley Road, Heidelberg, 3084, Victoria
Country 69059 0
Australia
Phone 69059 0
+61402450888
Fax 69059 0
Email 69059 0
[email protected]
Contact person for scientific queries
Name 69060 0
Dr Shannon McGrath
Address 69060 0
Austin Health Urology Department
Level 8 Harold Stokes Building,
Austin Hospital,
145 Studley Road, Heidelberg, 3084, Victoria
Country 69060 0
Australia
Phone 69060 0
+61402450888
Fax 69060 0
Email 69060 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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