PURPOSE: To our knowledge the optimal analgesia during prostate biopsy remains undetermined. We tested the efficacy and safety of combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block during transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: A total of 280 patients were randomized to receive combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block (group 1), perianal-intrarectal lidocaine-prilocaine cream alone (group 2), periprostatic nerve block alone (group 3) or no anesthesia (group 4) before transrectal ultrasound guided prostate biopsy. Pain was evaluated with a 10-point visual analog scale at subsequent procedural steps, including perianal-intrarectal substance administration, prostate transrectal ultrasound, periprostatic nerve block and sampling. Complications were assessed by self-administered questionnaire and telephone interview. RESULTS: The groups were comparable in patient age, prostate volume, pathology results and visual analog scale perianal-intrarectal substance administration. Visual analog scale results for transrectal ultrasound were lower in groups 1 and 2 vs 3 and 4 (mean 1.5 and 1.41 vs 5.37 and 5.31, p <0.001) and results for periprostatic nerve block were lower in group 1 vs 3 (mean 1.03 vs 3.74, p <0.001). Results for sampling were lower in groups 1 to 3 vs 4 (mean 0.77, 1.27 and 1.27 vs 4.33, p <0.001) and in group 1 vs 2 and 3 (p <0.001). Stratified analysis showed that visual analog scale sampling was lower in group 1 vs 2 and 3 in patients 65 years old or younger, those with a prostate greater than 49 cc and those with lower anorectal compliance (visual analog scale results for perianal-intrarectal substance administration greater than 2) (p = 0.006, <0.001 and 0.003, respectively). The overall complication rate was similar in all 4 groups (p = 0.87). CONCLUSIONS: Our findings suggest that the combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block provides better pain control than the 2 modalities alone during the sampling part of transrectal ultrasound guided prostate biopsy with no increase in the complication rate. The magnitude of this effect is higher in younger men, men with a larger prostate and men with lower anorectal compliance.
RCT Entities:
PURPOSE: To our knowledge the optimal analgesia during prostate biopsy remains undetermined. We tested the efficacy and safety of combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block during transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: A total of 280 patients were randomized to receive combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block (group 1), perianal-intrarectal lidocaine-prilocaine cream alone (group 2), periprostatic nerve block alone (group 3) or no anesthesia (group 4) before transrectal ultrasound guided prostate biopsy. Pain was evaluated with a 10-point visual analog scale at subsequent procedural steps, including perianal-intrarectal substance administration, prostate transrectal ultrasound, periprostatic nerve block and sampling. Complications were assessed by self-administered questionnaire and telephone interview. RESULTS: The groups were comparable in patient age, prostate volume, pathology results and visual analog scale perianal-intrarectal substance administration. Visual analog scale results for transrectal ultrasound were lower in groups 1 and 2 vs 3 and 4 (mean 1.5 and 1.41 vs 5.37 and 5.31, p <0.001) and results for periprostatic nerve block were lower in group 1 vs 3 (mean 1.03 vs 3.74, p <0.001). Results for sampling were lower in groups 1 to 3 vs 4 (mean 0.77, 1.27 and 1.27 vs 4.33, p <0.001) and in group 1 vs 2 and 3 (p <0.001). Stratified analysis showed that visual analog scale sampling was lower in group 1 vs 2 and 3 in patients 65 years old or younger, those with a prostate greater than 49 cc and those with lower anorectal compliance (visual analog scale results for perianal-intrarectal substance administration greater than 2) (p = 0.006, <0.001 and 0.003, respectively). The overall complication rate was similar in all 4 groups (p = 0.87). CONCLUSIONS: Our findings suggest that the combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block provides better pain control than the 2 modalities alone during the sampling part of transrectal ultrasound guided prostate biopsy with no increase in the complication rate. The magnitude of this effect is higher in younger men, men with a larger prostate and men with lower anorectal compliance.
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