'Multimodal' approach to management of prostate biopsy pain and effects on sexual function: efficacy of levobupivacaine adjuvant to diclofenac sodium - a prospective randomized trial.

We assessed the analgesic efficacy of levobupivacaine when administered as an adjuvant to diclofenac sodium in prostate biopsy pain management and effects of prostate biopsy on sexual function. Ninety patients underwent transrectal ultrasound (TRUS)-guided biopsy of the prostate and were randomly assigned to three groups: group D received diclofenac sodium suppository; Group L received periprostatic injection of levobupivacaine; group DL received diclofenac suppository and levobupivacaine in addition. Patients were asked to use a visual analogue scale score (VAS) questionnaire about pain after 10 core prostate biopsy. Sixty-two patients reported to be prostate cancer-free underwent further evaluation with the International Index of Erectile Function-5 (IIEF-5) questionnaire at 1 and 3 months after biopsy. Mean pain scores during prostate biopsy were significantly lower in group DL and were superior to the group L and group D (P < 0.001). Mean IIEF-5 score prior to biopsies was significantly higher when compared with the mean IIEF-5 score 1 month after biopsy (P < 0.0001). Mean IIEF-5 scores 1 month after biopsy were significantly lower when compared with the mean IIEF-5 scores 3 months after biopsy (P = 0.002). TRUS-guided prostate biopsies have a statistically significant impact on short-term erectile function, but this difference is not clinically significant; however, medium-term erectile function is not affected both statistically and clinically.

RCT Entities:   Population Interventions Outcomes