Comparison of intrarectal heated lidocaine gel and periprostatic nerve block for pain control in transrectal ultrasound-guided prostate biopsy: A randomized controlled non-inferiority trial

• Published in: Prostate international 2023-03, Vol.11 (1), p.8-12
• Main Authors: Jang, Hoon, Moon, Hee Nam, Kim, Jung Im, Bae, Sang Rak, Han, Chang Hee, Park, Bong Hee
• Format: Article
• Language: English
• Subjects: Biopsy; Local anesthesia; Pain; Prostate
• ISSN: 2287-8882; 2287-903X
• DOI: 10.1016/j.prnil.2022.07.004

To investigate whether intrarectal local anesthesia with heated lidocaine gel (IRLAH) is non-inferior to periprostatic nerve block (PNB) for reducing pain in patients undergoing transrectal ultrasound (TRUS)-guided prostate biopsy. We performed a randomized controlled non-inferiority trial with 100 participants who underwent systematic TRUS-guided, 12-core prostate biopsy from August 2019 to July 2020. These participants were randomly assigned to a group receiving intrarectal local anesthesia with 20 mL of heated (40°C) 2% lidocaine gel (n = 50) or PNB (n = 50). The primary outcome was a pain score on a 0–10 visual analogue scale (VAS) at four time points with the non-inferiority margin of 1; VAS-1: during local anesthesia application; VAS-2: during probe insertion; VAS-3: during biopsy; VAS-4: 30 minutes after the procedure. The secondary outcome included complications during and after the procedure. The IRLAH group (0.1) met non-inferiority as well as superiority criteria for mean VAS-1 score vs. the PNB group (2.33) (P