Clinical trial · Interventional
Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of TRUS B
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
NCT02604225CI-TRIAL-00045039TRUSBcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methoxyflurane | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Penthrox
- description
- Methoxyflurane
- interventionNames
- Drug: Methoxyflurane
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Saline 0.9%
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males older than 18 years scheduled to undergo a TRUS biopsy of the prostate. 2. Adequate liver function: ALT, AST, or bilirubin ≤ 2 x ULN 3. Adequate renal function: serum eGFR\> 30 ml/min/1.73m2 4. Willing and able to complete questionnaires in English 5. Willing and able to undergo TRUS biopsy within 7 days of randomisation 6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments 7. Signed, written informed consent Exclusion Criteria: 1. Previous TRUS biopsy of the prostate 2. Personal or family history of malignant hyperthermia 3. History of significant liver disease 4. Hypersensitivity to fluorinated anaesthetics or other inhalational anaesthetics 5. Concurrent use of barbiturates or tetracycline antibiotics 6. Concurrent illness that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety 7. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.