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Trial registered on ANZCTR


Registration number
ACTRN12621001143819
Ethics application status
Approved
Date submitted
19/07/2021
Date registered
25/08/2021
Date last updated
25/08/2021
Date data sharing statement initially provided
25/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised clinical trial comparing post-operative pain scores in patients with suspected prostate cancer undergoing transperineal prostate biopsy with and without a periprostatic nerve block under general anaesthesia.
Scientific title
A multi-centre, randomised trial of periprostatic nerve block in transperineal prostate biopsy under general anaesthesia in patients with suspected prostate cancer.
Secondary ID [1] 304819 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 322884 0
transperineal prostate biopsy 322885 0
post-operative pain 323075 0
Condition category
Condition code
Cancer 320463 320463 0 0
Prostate
Surgery 320464 320464 0 0
Surgical techniques
Anaesthesiology 320653 320653 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants in this study will undergo transperineal prostate biopsy under general anaesthesia (GA) by an expert urologist as part of their diagnostic process for suspected prostate cancer. If randomised to the treatment group i.e. the periprostatic nerve block (PPNB) group, participants will receive an additional injection of weight-based 1% lignocaine with adrenaline (1:200000), 6-7mg/kg with maximum dose not to exceed 500mg (UofIowa protocol). This injection will be administered just before biopsy and after GA administration and is anticipated to provide at least 2 hours of analgesia. An uncomplicated biopsy procedure is estimated to take about 20-25 minutes.
Intervention code [1] 321186 0
Treatment: Drugs
Comparator / control treatment
For the first 10 participants recruited, a feasibility run-in period with PPNB vs no injection (non-placebo) will be executed to examine introduction of researcher bias in post-operative pain management as an open-label trial. Results of the feasibility run-in period will decide whether to proceed with non-placebo or placebo controlled trial.
In the event of a placebo-controlled trial, the comparator group will receive an injection of 0.9% normal saline in their perineal regions while under GA. However, in the event of a non-placebo controlled trial, the study continues without changes to methodology administering no additional injection to participants in the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 328298 0
Post-operative pain scores assessed using the 100mm Visual Analogue Scale (VAS)
Timepoint [1] 328298 0
Assessed once only after the biopsy procedure, after participant has been shifted to recovery and is fully awake and out of effects of general anaesthesia approximately 2 hours post-procedure and always within 24 hours. Participants will be asked to rate their worst level of pain they experienced post-procedure.
Secondary outcome [1] 398476 0
Rate and severity of post-operative complications as a composite outcome according to the Clavien-Dindo Classification. This data will be collected during the patients stay in recovery and visits to the ER/Doctors office after discharge, with conditions possibly associated with the biopsy procedure. Medical records will be screened to collect this data.
Timepoint [1] 398476 0
T1: recorded immediately after procedure till the participant is discharged. Participants are under constant watch till discharge and so specific timepoints i.e. 10 mins or 30 mins etc are not required.
T2: From participants' discharge from the hospital till up to 7 days post-procedure.
Secondary outcome [2] 398477 0
use of additional analgesia post-operatively, in mg of morphine equivalent. Collected from medical records.
Timepoint [2] 398477 0
After the participant is moved out of the operating theatres and in to recovery until they are discharged from the hospital. This is usually a two hours window.

Eligibility
Key inclusion criteria
1. Patients undergoing transperineal prostate biopsy.
2. Patients who can provide informed consent for participation in this study.

Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any patient who cannot provide informed consent or is unwilling to participate in this study.
2. Any patient who has received a locoregional nerve block in the 24 hours prior to transperineal nerve block.
3. Any patient with a history of anaphylaxis following local anaesthetic injection.
4. Any patient unable to communicate, read or write in English to a level where they are able to understand the study and consent to inclusion.


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)
There will be 1:1 randomisation of patients and randomisation sequences will be computer generated by a validated online program www.randomizer.org, using blocking with randomly select block sizes of 2, 4, and 6. Randomisation will be stratified by treating surgeon.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
If the trial proceeds as non-placebo controlled (PPNB vs no injection), the participants, people assessing the outcomes and those analysing results/data will be blinded only. The surgeon administering the injection and performing the biopsy will automatically be unblinded.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
In order to detect a significant difference between groups with a mean VAS pain score of 3 (SD 1.75) in the non-local anaesthetic group and 1.5 (SD 1.75) in the local anaesthetic group, with 80% power and at a 5% significance level, n=22 patients per group are required. In order to allow for dropout, the investigators aim to recruit 25 patients to each arm of the study.

Descriptive statistics will be presented by treatment group at baseline. Post-operative VAS score will be compared between groups via an unpaired t-test if the scores are normally distributed, or a Mann-Whitney test if the scores are not normally distributed. Analysis will be performed on an intention-to-treat basis. Complete case analysis will be used.

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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19999 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 20000 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 34707 0
2050 - Camperdown
Recruitment postcode(s) [2] 34708 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 309190 0
Hospital
Name [1] 309190 0
Chris O'Brien Lifehouse
Address [1] 309190 0
119-143 Missenden Road, Camperdown New South Wales 2050
Country [1] 309190 0
Australia
Funding source category [2] 309193 0
Hospital
Name [2] 309193 0
Sydney Adventist Hospital
Address [2] 309193 0
185 Fox Valley Road
Wahroonga NSW 2076
Country [2] 309193 0
Australia
Primary sponsor type
Hospital
Name
Chris O Brien Lifehouse
Address
119-143 Missenden Road, Camperdown New South Wales 2050
Country
Australia
Secondary sponsor category [1] 310151 0
Hospital
Name [1] 310151 0
Sydney Adventist Hospitals
Address [1] 310151 0
185 Fox Valley Road, Wahroonga NSW 2076
Country [1] 310151 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309046 0
SLHD HREC Concord Repatriation General Hospital
Ethics committee address [1] 309046 0
Concord Concord Repatriation General Hospital
Hospital Road, Concord New South Wales 2139
Ethics committee country [1] 309046 0
Australia
Date submitted for ethics approval [1] 309046 0
16/12/2020
Approval date [1] 309046 0
28/05/2021
Ethics approval number [1] 309046 0
2020/ETH03024

Summary
Brief summary
This study aims to determine if local anaesthetic injected around the prostate reduces pain after prostate biopsies under general anaesthesia.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and are undergoing planned transperineal prostate biopsy for suspected prostate cancer.

Study Details
All participants in this study will undergo a transperineal prostate biopsy under general anaesthesia.

This study will be completed in two parts:
In part one, 10 participants will be recruited, and they will be placed into two groups by chance to receive a local anaesthetic periprostatic nerve block of 1% lignocaine with adrenaline or to receive no injection while under general anaesthetic. Depending on the results of this part of the study, we will determine whether a placebo is required for part 2 of this study.

In part two, if results of part 1 show that a placebo is necessary for the study to continue, the trial will recruit 50 participants to receive the same injection as part 1 (1% lignocaine with adrenaline) or receive a placebo (non-active injection of normal saline).

If results of part 1 show a placebo is not necessary, the trial will continue the same way and recruit 40 more participants.

After the procedure, the participants will be asked to rate their worst level of pain and be monitored for additional analgesia and complications (if any).

All participants will be recruited via clinics of and by the two treating surgeons with biopsies performed in the adjoining hospitals.

It is hoped that this trial will provide information on patient reported outcomes to improve transperineal prostate biopsy techniques making them more tolerable, as patients may be expected to undergo more than one such procedures in the course of prostate cancer diagnosis and treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112774 0
Prof Henry Woo
Address 112774 0
Suite 406
San Clinic
185 Fox Valley Road
Wahroonga NSW 2076
Country 112774 0
Australia
Phone 112774 0
+61 410608765
Fax 112774 0
Email 112774 0
hwoo@urologist.net.au
Contact person for public queries
Name 112775 0
Dr Hadia Khanani
Address 112775 0
SAN Prostate Centre of Excellence
Sydney Adventist Hospital
185 Fox Valley Road
Wahroonga NSW 2076
Country 112775 0
Australia
Phone 112775 0
+61 411 521 970
Fax 112775 0
Email 112775 0
dr.h.khanani@gmail.com
Contact person for scientific queries
Name 112776 0
Prof Henry Woo
Address 112776 0
Suite 406
San Clinic
185 Fox Valley Road
Wahroonga NSW 2076
Country 112776 0
Australia
Phone 112776 0
+61 410608765
Fax 112776 0
Email 112776 0
hwoo@urologist.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data on the tolerability of transperineal prostate biopsies in conjunction with PPNB vs placebo/non-placebo will be shared after analysis
When will data be available (start and end dates)?
Following publication with no end date decided
Available to whom?
The data will be available to the public via publication.
Available for what types of analyses?
none specific
How or where can data be obtained?
upon request from authors of the publication. The authors have the right to accept or reject such requests. emails for requests to be sent to dr.h.khanani@gmail.com (Research Fellow) overseeing clinical trials.
What supporting documents are/will be available?
No other documents available
Summary results
No Results