Evidence map›Paper›PMID 34273231›Full record

Trial reportBJU international2022

'Pain-free TRUS B': a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501).

Dickon Hayne, Jeremy Grummet, David Espinoza, Steve P McCombie, Venu Chalasani, Kate S Ford, Mark Frydenberg, Peter Gilling, Barbara Gordon, Cynthia Hawks and 14 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJU international, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06899724 (A Randomized Multicentre Placebo Controlled Non-inferiority Study of Intravenous Sedation Versus Methoxyflurane During Hysteroscopy.), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06899724 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Multicentre Placebo Controlled Non-inferiority Study of Intravenous Sedation Versus Methoxyflurane During Hysteroscopy.

TypeinterventionalSponsorDr. John A. Thiel Medical Professional CorporationRan2025 to 2026Enrolled54ConditionsAnalgesiaArmsAnesthetics, Inhalation, Intravenous Sedatives with or Without Analgesia
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Literature review on the use of methoxyflurane in the management of pain in cancer-related procedures.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 13 institutions in 2 countries.

Dickon HayneUWA Medical School, University of Western Australia, Perth, WA, Australia.ORCID 0000-0002-4094-401X
Jeremy GrummetAlfred Health, Central Clinical School, Monash University, Melbourne, Vic., Australia.
David EspinozaNHMRC Clinical Trials Centre, Sydney, NSW, Australia.
Steve P McCombieUWA Medical School, University of Western Australia, Perth, WA, Australia.ORCID 0000-0002-3920-994X
Venu ChalasaniSydney Adventist Hospital, Sydney, NSW, Australia.
Kate S FordNHMRC Clinical Trials Centre, Sydney, NSW, Australia.ORCID 0000-0002-3630-8141
Mark FrydenbergDepartment of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Vic., Australia.
Peter GillingTauranga Urology Research, Tauranga, New Zealand.ORCID 0000-0002-3118-1655
Barbara GordonCanterbury Urology Research Trust, Christchurch, New Zealand.
Cynthia HawksUWA Medical School, University of Western Australia, Perth, WA, Australia.ORCID 0000-0001-7848-9537
Alex KonstantatosAlfred Health, Central Clinical School, Monash University, Melbourne, Vic., Australia.
Andrew J MartinDepartment of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Vic., Australia.
Anthony NixonCardinal Points Research, Whangarei, New Zealand.
Colin O'BrienConsumer Advisory Panel, Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), Sydney, NSW, Australia.
Manish I PatelDiscipline of Surgery, Westmead Hospital, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0003-1409-9171
Shomik SenguptaDepartment of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Vic., Australia.ORCID 0000-0003-3357-1216
Shekib ShahbazMonash Health, Casey Hospital, Melbourne, Vic., Australia.
Shalini SubramaniamDepartment of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Vic., Australia.ORCID 0000-0003-2138-8633
Scott WilliamsPeter MacCallum Cancer Centre, Melbourne, Vic., Australia.
Henry H WooSydney Adventist Hospital, Sydney, NSW, Australia.ORCID 0000-0003-4099-0339
Martin R StocklerDepartment of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Vic., Australia.
Ian D DavisEastern Health Clinical School, Monash University, Melbourne, Vic., Australia.
Nick BuchanCanterbury Urology Research Trust, Christchurch, New Zealand.
Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Monash Health · AUThe University of Western Australia · AUChristchurch Clinical Studies Trust · NZEastern Health · AUMonash Alfred Psychiatry Research centre · AURespiratory Clinical Trials · AUSydney Adventist Hospital · AUAustralian and New Zealand Urogenital and Prostate Cancer Trials Group · AUCabrini Hospital · AUNorthland District Health Board · NZPeter MacCallum Cancer Centre · AUTauranga Hospital · NZThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine whether the addition of inhaled methoxyflurane to periprostatic infiltration of local anaesthetic (PILA) during transrectal ultrasonography-guided prostate biopsies (TRUSBs) improved pain and other aspects of the experience. PATIENTS AND

methodsWe conducted a multicentre, placebo-controlled, double-blind, randomized phase 3 trial, involving 420 men undergoing their first TRUSB. The intervention was PILA plus a patient-controlled device containing either 3 mL methoxyflurane, or 3 mL 0.9% saline plus one drop of methoxyflurane to preserve blinding. The primary outcome was the pain score (0-10) reported by the participant after 15 min. Secondary outcomes included ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events.

resultsThe mean (SE) pain scores 15 min after TRUSB were 2.51 (0.22) in those assigned methoxyflurane vs 2.82 (0.22) for placebo (difference 0.31, 95% confidence interval [CI] -0.75 to 0.14; P = 0.18). Methoxyflurane was associated with better scores for discomfort (difference -0.48, 95% CI -0.92 to -0.03; P = 0.035, adjusted [adj.] P = 0.076), whole experience (difference -0.50, 95% CI -0.92 to -0.08; P = 0.021, adj. P = 0.053), and willingness to undergo repeat biopsies (odds ratio 1.67, 95% CI 1.12-2.49; P = 0.01) than placebo. Methoxyflurane resulted in higher scores for drowsiness (difference +1.64, 95% CI 1.21-2.07; P < 0.001, adj. P < 0.001) and dizziness (difference +1.78, 95% CI 1.31-2.24; P < 0.001, adj. P < 0.001) than placebo. There was no significant difference in the number of ≥ grade 3 adverse events.

conclusionsWe found no evidence that methoxyflurane improved pain scores at 15 min, however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

Indexed as

ProstateProstatic NeoplasmsAnesthesia, LocalAnesthetics, LocalBiopsyHumansLidocaineMaleMethoxyfluranePainPain MeasurementUltrasonographyAnesthetics, LocalLidocaineMethoxyfluranebiopsymethoxyfluranepain#PCSMprostate#ProstateCancerprostatic neoplasms

Identifiers

PMID34273231
PMCPMC9291594
OpenAlexW3185101111

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.