Lidocaine–Prilocaine Administration during Transrectal Ultrasound-Guided Prostatic Biopsy: A Randomized, Single-Blind, Placebo-Controlled Trial

Abstract

As many as 96% of patients report some kind of discomfort/pain during transrectal ultrasonography (TRUS)-guided prostate biopsy, and when pain is severe, it may be necessary to decrease the planned number of biopsies or interrupt the procedure. Various modalities have been recommended to alleviate the pain, but reports on efficacy are contradictory. We assessed the possible benefit of intrarectal and perianal lidocaine-prilocaine (EMLA) cream. A series of 98 patients without active anal and prostatic conditions underwent TRUS and, 10 to 31 days later, TRUS-guided biopsy. They were asked to grade their discomfort/pain using a 10- point linear visual analog pain scale (VAS). After TRUS, patients were divided into three groups on the basis of the VAS scores. Group 1 (N = 8) had pain scores <or=2 (mild pain/discomfort). Group 2 (N = 75) had pain scores between 2 and 5 (moderate pain/discomfort). Group 3 (N = 15) had pain scores >or=5 (severe pain/discomfort). Each group was then randomized to receive local anesthesia with intrarectal and anal EMLA cream (subgroup A) or intrarectal and anal ultrasound gel as placebo (subgroup B). Pain scoring was repeated after the biopsy. In group 1, there were no significant differences in pain scores between subgroups A and B. In group 2, we could not complete the biopsy in one patient of subgroup B. A statistically significant difference was noticed between the VAS scores of subgroup A and subgroup B (P < 0.0001). In group 3, we were not able to complete biopsy in 5 patients of subgroup B. We noticed significantly higher VAS scores in subgroup B between TRUS and prostate biopsy (P < 0.0001), whereas similar scores were observed in subgroup A (P = NS). A statistically significant difference (P < 0.0001) was noticed between subgroup A and subgroup B scores during biopsy. In patients with high tolerance for simple TRUS, needle trauma does not significantly alter tolerability, and anesthetic provides little benefit for prostatic biopsy. However, the opposite is true in patients presenting moderate to significant pain/discomfort at TRUS, who may benefit from intrarectal/anal administration of EMLA during prostate biopsy.