Journal article
‘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)
D Hayne, J Grummet, D Espinoza, SP McCombie, V Chalasani, KS Ford, M Frydenberg, P Gilling, B Gordon, C Hawks, A Konstantatos, AJ Martin, A Nixon, C O’Brien, MI Patel, S Sengupta, S Shahbaz, S Subramaniam, S Williams, HH Woo Show all
BJU International | WILEY | Published : 2022
DOI: 10.1111/bju.15552
Open access
Abstract
Objective: To 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 Methods: We 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 ratin..
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Awarded by Amgen
Funding Acknowledgements
We thank the participants and their families for their contribution. We also thank the principal investigators, co-investigators and study coordinators at all participating centres for their commitment to this trial. Lead Collaborative group: ANZUP Cancer Trials Group Limited. Study Sponsor: The University of Sydney. Investigational Product: Medical Developments International. ANZUP receives infrastructure funding from Cancer Australia. Ian Davis was supported by an NHMRC Practitioner Fellowship (APP1102604). Funding was received from the Cancer Australia Priority-driven Collaborative Cancer Research Scheme (APP1079794).