Jang Hoon, Moon Hee Nam, Kim Jung Im, Bae Sang Rak, Han Chang Hee, Park Bong Hee
Department of Urology, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Nursing, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
Prostate Int. 2023 Mar;11(1):8-12. doi: 10.1016/j.prnil.2022.07.004. Epub 2022 Aug 5.
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) ( < 0.001), as the difference (95% confidence interval [CI]) between the two groups was -2.23 (-2.66 to -1.79) and the upper bound of the 95% CI were both below the prespecified non-inferiority margin and below zero. For mean VAS-3 score, the difference (95% CI) was 0.3 (-0.38 to 0.98) and the upper bound of the 95% CI did not exceed the predefined non-inferiority margin indicating that IRLAH was non-inferior (IRLAH group, 3.44; PNB group, 3.14). Also, non-inferiority was shown for pain scores at VAS-2 and VAS-4. There were no significant differences in complications.
IRLAH is a noninvasive and non-inferior alternative to PNB for pain control in TRUS-guided prostate biopsy without increased risk of complications.
探讨经直肠超声（TRUS）引导下前列腺穿刺活检患者中，直肠内注入温热利多卡因凝胶局部麻醉（IRLAH）在减轻疼痛方面是否不劣于前列腺周围神经阻滞（PNB）。
我们进行了一项随机对照非劣效性试验，纳入了100例在2019年8月至2020年7月期间接受系统TRUS引导下12针前列腺穿刺活检的参与者。这些参与者被随机分配至两组，一组接受直肠内注入20 mL温热（40°C）2%利多卡因凝胶局部麻醉（n = 50），另一组接受PNB（n = 50）。主要结局是在四个时间点采用0-10视觉模拟评分法（VAS）评估的疼痛评分，非劣效界值为1；VAS-1：局部麻醉应用期间；VAS-2：探头插入期间；VAS-3：穿刺活检期间；VAS-4：操作后30分钟。次要结局包括操作期间及操作后的并发症。
IRLAH组（0.1）在VAS-1平均评分方面达到了非劣效性及优效性标准，与PNB组（2.33）相比（P < 0.001），两组间差异（95%置信区间[CI]）为-2.23（-2.66至-1.79），95%CI的上限均低于预先设定的非劣效界值且低于零。对于VAS-3平均评分，差异（95%CI）为0.3（-0.38至0.98），95%CI的上限未超过预先定义的非劣效界值，表明IRLAH不劣于PNB（IRLAH组，3.44；PNB组，3.14）。此外，在VAS-2和VAS-4疼痛评分方面也显示出非劣效性。并发症方面无显著差异。
在TRUS引导下前列腺穿刺活检的疼痛控制中，IRLAH是一种无创且不劣于PNB的替代方法，且不会增加并发症风险。
