UWA Medical School, University of Western Australia, Perth, WA, Australia.
Fiona Stanley Hospital, Perth, WA, Australia.
BJU Int. 2022 May;129(5):591-600. doi: 10.1111/bju.15552. Epub 2021 Jul 30.
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.
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 ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events.
The 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.
We 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.
确定在经直肠超声引导前列腺活检（TRUSB）中，前列腺周围浸润局部麻醉（PILA）时加入吸入甲氧氟烷是否能改善疼痛和其他方面的体验。
我们进行了一项多中心、安慰剂对照、双盲、随机 3 期临床试验，涉及 420 名接受首次 TRUSB 的男性。干预措施是 PILA 加一个包含 3 毫升甲氧氟烷的患者自控装置，或 3 毫升 0.9%生理盐水加一滴甲氧氟烷以保持盲法。主要结局是参与者在 15 分钟后报告的疼痛评分（0-10）。次要结局包括对活检体验其他方面的评分、接受未来活检的意愿、泌尿科医生的评分、活检完成情况和不良事件。
TRUSB 后 15 分钟，接受甲氧氟烷组的平均（SE）疼痛评分（2.51（0.22））低于安慰剂组（2.82（0.22））（差异 0.31，95%置信区间 [CI] -0.75 至 0.14；P = 0.18）。甲氧氟烷与不适感评分的改善相关（差异 -0.48，95% CI -0.92 至 -0.03；P = 0.035，调整后 [adj.] P = 0.076），整个体验（差异 -0.50，95% CI -0.92 至 -0.08；P = 0.021，adj. P = 0.053），以及接受重复活检的意愿（比值比 1.67，95% CI 1.12-2.49；P = 0.01）高于安慰剂。甲氧氟烷引起的困倦评分（差异 +1.64，95% CI 1.21-2.07；P < 0.001，adj. P < 0.001）和头晕评分（差异 +1.78，95% CI 1.31-2.24；P < 0.001，adj. P < 0.001）高于安慰剂。≥3 级不良事件的数量无显著差异。
我们没有发现甲氧氟烷能在 15 分钟时改善疼痛评分的证据，但在患者报告的不适、整体体验和接受重复活检的意愿方面有改善。
