Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial

Background: Recent evidence suggests that additional analgesic regimens to periprostatic nerve block (PPNB) anesthesia provide substantial pain relief during transrectal ultrasound-guided prostate biopsy. In this regard, we investigated the efficacy and safety of tramadol alone or in combination with parecoxib as adjunct regimens to PPNB anesthesia. Material and Methods: A total of 51 participants were randomly allocated into three study groups: Group 1 received PPNB anesthesia, Group 2 received tramadol and PPNB anesthesia, whereas Group 3 received both tramadol and parecoxib as adjunct regimens to PPNB anesthesia. The pain was evaluated at three different time points during biopsy: at the time of probe insertion (NRS1), at the time of PPNB anesthesia (NRS2), and at the time of the actual biopsy itself (NRS3), using a numeric rating scale (NRS) of pain. Safety was evaluated by the occurrence of complications and adverse effects. Results: The mean NRS1 score was statistically significantly different in Groups 2 and 3 than in Group 1 (2.4 +/- 1.3 and 1.1 +/- 1.2 vs. 4.5 +/- 1.8; p < 0.0167). We found a statistically significant difference regarding NRS 2 score in Groups 2 and 3 than in Group 1 (2.6 +/- 1.4 and 1.1 +/- 1.3 vs. 4.1 +/- 1.3; p < 0.0167). The mean NRS1 and NRS2 scores were found to be statistically significantly different in Group 3 than in Group 2 (1.1 +/- 1.2 vs. 2.4 +/- 1.3 as well as 1.1 +/- 1.3 vs. 2.6 +/- 1.4; p < 0.0167). Also, a statistically significant difference was found between Groups 2 and 3 regarding hematuria episodes [0 (0.0) vs. 5 (29.4); p < 0.0167]. Conclusion: Tramadol as an adjunct regimen to PPNB anesthesia is a safe and straightforward technique that provides a significant analgesic effect. The effectiveness is even higher when tramadol is combined with parecoxib.