'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, Alex Konstantatos, Andrew J Martin, Anthony Nixon, Colin O'Brien, Manish Patel, Shomik Sengupta, Shekib Shahbaz, Shalini Subramaniam, Scott Williams, Henry H Woo Show all
BJU INTERNATIONAL | WILEY | Published : 2021
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..View full abstract
Awarded by NHMRC Practitioner Fellowship
Awarded by Cancer Australia Priority-driven Collaborative Cancer Research Scheme
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).