Perineal nerve block versus periprostatic block for patients undergoing transperineal prostate biopsy (APROPOS): a prospective, multicentre, randomised controlled study
作者:Biming He, Peter Ka‐Fung Chiu, Tao Tao, Jian-Hua Lan, Jian-Tong Cai, Sheng-Cai Zhou, Rongbing Li, Yan Ren, Ka-Lun Lo, Rong-Yao Xu, Jianrong Chen, Dong Lan, Jin-Li Gao, Shu-Guang Chu, Zhichao Jin, Fang-fang Huang, Zhenkai Shi, Qiwei Yang, Hai Zhou, Shuai-Dong Wang, Tang-Rao Ji, Qipeng Han, Changming Wang, Chi‐Fai Ng, Haifeng Wang, Haifeng Wang, Biming He, Ronbing Li, Yan Ren, Zhenkai Shi, Qiwei Yang, Shuaidong Wang, Hai Zhou, Tang-Rao Ji, Jin-Li Gao, Shu-Guang Chu, Fang-fang Huang, Peter Ka‐Fung Chiu, Ka-Lun Lo, Chi‐Fai Ng, Tao Tao, Changming Wang, Deyun Shen, Xiangyu Mu, Bin Zhang, Rong-Yao Xu, Jianrong Chen, Jiantong Chai, Shaopeng Li, Zong-Qi Lin, Le Yu, Yihua Zhang, Dong Lan, Jian-Hua Lan, Qiao Ying, Zhulin Dai, Lin Yang, Yujie Luo, Qiang Lin, Sheng-Cai Zhou, Qipeng Han, Shubin Si, Chen Song, Liang Hu, Zhichao Jin · 发表于:EClinicalMedicine · 年份:2023 · DOI:10.1016/j.eclinm.2023.101919 · 被引用次数:14 · 研究领域:Prostate Cancer Diagnosis and Treatment、Anesthesia and Pain Management、Urinary Bladder and Prostate Research
Background: We aimed to investigate perineal nerve block versus periprostatic block in pain control for men undergoing a transperineal prostate biopsy. Methods: In this prospective, randomised, blinded and parallel-group trial, men in six Chinese hospitals with suspected prostate cancer were randomly assigned (1:1) at the point of local anaesthesia to receive a perineal nerve block or periprostatic block and followed by a transperineal prostate biopsy. Centres used their usual biopsy procedure. Operators who performed anaesthesia were trained in both techniques before the trial and were masked to the randomised allocation until the time of anaesthesia and were not involved in the subsequent biopsy procedure and any assessment or analysis. Other investigators and the patients were masked until trial completion. The primary outcome was the level of the worst pain experienced during the prostate biopsy procedure. Secondary outcomes included pain (post-biopsy at 1, 6 and 24 h), changes in blood pressure, heart rate and breathing rate during the biopsy procedure, external manifestations of pain during biopsy, anaesthesia satisfaction, the detection rate of PCa and clinically significant PCa. This trial is registered on ClinicalTrials.gov, NCT04501055. Findings: Between August 13, 2020, and July 20, 2022, 192 men were randomly assigned to perineal nerve block or periprostatic block, 96 per study group. Perineal nerve block was superior for the relief of pain during the biopsy proce...