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Perianal and intrarectal anaesthesia for transrectal biopsy of the prostate: a prospective randomized study comparing lidocaine‐prilocaine cream and placebo
Author(s) -
DE MARIA MAURIZIO,
MOGOROVICH ANDREA,
GIANNARINI GIANLUCA,
SELLI CESARE
Publication year - 2006
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2006.06228_1.x
Subject(s) - medicine , prilocaine , visual analogue scale , lidocaine , randomized controlled trial , placebo , anesthesia , surgery , alternative medicine , pathology
11 2 1 was already reported in two randomized clinical trials [3,4]. (ii) It is quite striking that all men in the placebo group completed the 12-core sampling; in the four-arm randomized trial by Galosi et al. [5], in 10% and 15% of patients in the placebo and notreatment group, respectively, the scheduled six-core biopsy session had to be prematurely interrupted due to intolerable pain, and in our series in 14% of the placebo group. The reason for this is probably the discrepancy in mean VAS score among the placebo groups of the studies, i.e. 1.6 during probe insertion and 3.2 during biopsy puncture in the series by Raber et al. [1], 5 (overall) in that reported by Basar et al. [4], and 5.5 (overall) in our series. The lower pain score in the series of Raber et al. might be due either to a less disturbing ultrasound probe or even to selection bias, but we are concerned about the representativity of the population, which could have consequently altered the real benefit of lidocaine-prilocaine anaesthesia. (iii) We agree with the authors that pain during prostate biopsy comes from both the insertion/residence of the TRUS probe into the anal canal and the biopsy punctures through the rectal mucosa, and we are convinced that the application of the anaesthetic cream should involve both locations. Accordingly, in our trial we first stratified the patients by discomfort/pain during simple TRUS at the initial clinical evaluation, and then randomized them to lidocaine-prilocaine or placebo for the subsequent prostate biopsy. Our analysis showed that in men with high compliance at TRUS, needle trauma did not significantly alter the tolerability, and that anaesthetic administration added little benefit for the subsequent biopsy; the opposite was found in patients with discomfort/pain of medium and high degree at initial TRUS, who benefited from local anaesthesia during the biopsy. On the contrary, stratification by age did not result in a statistically significant difference, unlike the result reported by Raber et al. Given that the studies so far addressing the issue of pain relief during prostate biopsy have resulted in controversial findings, as shown by many medical centres around the world still using or until recently using it routinely with no anaesthesia, we think that the anaesthesia should be reserved only for selected patients. These might be, e.g. the ‘younger’ ones ( < 67 years old), as suggested by Raber et al. , or those with high compliance (VAS score ≤ 2) to simple TRUS, as advised by us. Further studies aimed at seeking men potentially benefiting from pain control are, in our opinion, mandatory, before anaesthesia can be recommended as a standard procedure during prostate biopsy.