Combined perianal-intrarectal (PI) lidocaine-prilocaine (LP) cream and lidocaine-ketorolac gel provide better pain relief than combined PI LP cream and periprostatic nerve block during transrectal prostate biopsy.

UNLABELLED: What's known on the subject? and What does the study add? Study Type - Harm Reduction RCT Level of Evidence 1b The combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block effectively counteracts probe and sampling related pain during transrectal prostate biopsy, but not pain due to periprostatic infiltration. The novel combination of lidocaine-prilocaine cream and lidocaine-ketorolac gel, both administered perianal-intrarectally, provides the same probe and sampling-related pain relief than combined perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block and prevents the non-negligible pain due to periprostatic infiltration, thus leading to better overall patients' compliance to the procedure.
OBJECTIVE: • To compare the efficacy and safety of combined perianal-intrarectal (PI) lidocaine-prilocaine (LP) cream and lidocaine-ketorolac (LK) gel with combined PI LP cream and periprostatic nerve block (PPNB) in relieving pain during transrectal ultrasonography guided prostate biopsy (TPB). PATIENTS AND METHODS: • In all, 200 patients were randomized to receive combined PI LP cream and LK gel (group 1) or combined PI LP cream and PPNB (group 2) before TPB. • The 0-10-point visual analogue scale (VAS) was used for assessing pain at probe insertion and movements (VAS-1), periprostatic infiltration (VAS-2) when applied, and prostate sampling (VAS-3), as well as maximal procedural pain (MPP). • Complications occurring ≤ 20 days after the TPB were recorded.
RESULTS: • The groups were comparable for patients' age, serum PSA level, prostate volume, and cancer detection rate. • All patients tolerated the procedure well. The two anaesthetic regimens provided almost equal mean VAS-1 (0.33 vs 0.37; P= 0.701) and VAS-3 (0.52 vs 0.51; P= 0.954) scores, but patients in group 2 reported significantly greater MPP scores (0.68 vs 1.53; P < 0.001) as periprostatic infiltration was the most painful part of the procedure (mean VAS-2: 1.33). • Complications rate was similar in the two groups (1% vs 2%; P= 0.38).
CONCLUSIONS: • The novel combination of PI LP cream and LK gel provided the same probe- and sampling- related pain relief as combined PI LP and PPNB; moreover, by preventing the non-negligible periprostatic infiltration pain, it provided significantly better overall patients' compliance to the procedure. • Being safe and easy to administer, this novel non-infiltrative regimen has the potential to replace infiltrative anaesthesia in relieving pain during TPB.

RCT Entities:   Population Interventions Outcomes