CompletedPhase 3

Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of TRUS B

Australia420 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 range18 Years

SexMALE

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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
✓. Adequate renal function: serum eGFR\> 30 ml/min/1.73m2
✓. 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
✕. 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.

What they're measuring

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

Trial details

NCT IDNCT02604225

SponsorUniversity of Sydney

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-05

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