Comparison of the Effect of Intra-Rectal Administration of Lidocaine Gel and Lidocaine Plus Fentanyl on Pain Reduction in Prostate Biopsy: A Randomized Clinical Trial

OBJECTIVES: The aim of this study was to compare the effect of intra-rectal administration of lidocaine gel alone versus lidocaine gel plus topical fentanyl on pain reduction in prostate biopsy. METHODS: In a double-blind randomized clinical trial, 96 patients who met the inclusion criteria were randomly assigned into two groups. 1) The treatment group: Lidocaine gel (2%) 50 g and 2) the intervention group: Lidocaine gel (2%) 50 g and fentanyl gel 50 µg. During the prostate biopsy, the VAS score was recorded. Blood pressure, heart rate, and patient level of consciousness were also analyzed. RESULTS: The mean VAS score was 5.1 ± 2 and 3.0 ± 2, which was lower in the intervention group (P value < 0.001). In terms of consciousness after biopsy, there was no difference between the two groups (P value = 0.358). There was no difference between the groups in terms of mean blood pressure and heart rate before and during the prostate biopsy. Finally, in terms of consciousness after the prostate biopsy, there was no difference between the current treatment and intervention groups. CONCLUSIONS: The combination of lidocaine gel and fentanyl with a dose of 50 µg has a significant effect on reducing the pain associated with prostate biopsy in comparison with lidocaine gel alone. The antinociceptive effect of the above regimens is not associated with hemodynamic changes and changes in patients' consciousness.