Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of TRUS B (NCT02604225) | Clinical Trial Compass
CompletedPhase 3
Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of TRUS B
Australia, New Zealand420 participantsStarted 2015-12
Plain-language summary
A phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasound-guided prostate biopsy (Pain-Free TRUS B).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males older than 18 years scheduled to undergo a TRUS biopsy of the prostate.
. Adequate liver function: ALT, AST, or bilirubin ≤ 2 x ULN
. Willing and able to complete questionnaires in English
. Willing and able to undergo TRUS biopsy within 7 days of randomisation
. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
. Signed, written informed consent
Exclusion criteria
. Previous TRUS biopsy of the prostate
. Personal or family history of malignant hyperthermia
. History of significant liver disease
. Hypersensitivity to fluorinated anaesthetics or other inhalational anaesthetics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain rated by participants will be self-rated using a numeric rating scale with verbal anchors from 0 (no trouble at all) to 10 (worst I can imagine).
Timeframe: Pain will be assessed at 15 minutes after the TRUS biopsy
. Concurrent use of barbiturates or tetracycline antibiotics
. Concurrent illness that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.