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临床试验/NCT03500432
NCT03500432已完成不适用

A Novel, Repeatable, and Effective Local Anesthesia Method for Transperineal Prostate biopsy-a Single Center Randomized Controlled Trial

Second Military Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
highest VAS scores

研究概览

简要总结

In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the advantage of better sampling from the anterior area, low risk of infection, and no rectal bleeding. The main problems associated with the transperineal method are pain control and additional general or spinal anesthesia. Three types of anesthesia have been reported for transperineal prostate biopsy: (1) spinal anesthesia; (2) general anesthesia; and (3) local anesthesia. From the viewpoint of patient selection (general anesthesia is contraindicated in some patients) and medical cost, local anesthesia is the most suitable choice for prostate biopsy. Periprostatic block is the standard method of local anesthesia for this procedure. However, periprostatic block is insufficient for transperineal prostate biopsy due to high pain sensitivity in this region. A number of new methods to eliminate pain have been reported, including (1) periapical triangle (PAT) block, (2) paraprostatic plus sexual nerve block, and (3) periprostatic block plus pudendal block.However, there is no anatomical basis for some of these methods, and there have been no randomized controlled trials to evaluate their effectiveness, and some methods are technically difficult to learn. In the previous perineal nerve autopsy, we found that there are two branches leading into the prostate and anterior lateral prostatic tissue, which is the main site of puncture pain. There is a fixed position where the two branches appear. Therefore, this anatomical position block may be a useful site for local anesthesia. We named this location the 'transperineal prostate biopsy local anesthesia switch' (abbreviated as TPA switch). In order to validate its effect, we organized this clinical trail.

详细描述

Ninety patients scheduled for prostate biopsy will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into three groups (Figure 1): group 1, subcutaneous local anesthesia+periprostatic block; group 2, subcutaneous local anesthesia+periapical triangle (PAT) block; group 3, subcutaneous local anesthesia+TPA switch (transperineal prostate biopsy local anesthesia switch) block; VAS scores for each puncture and complications will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 1. ready to be performed transperineal prostate biopsy;
  • fully understand the protocol and aggree to undergo prostate biopsy with local anesthesia which might be elder methods or new experimental method.

排除标准

  • 1.do not have the history of anaphylaxis or local anesthetic intoxation;
  • cardiac dysfunction or coagulation dysfunction;
  • Rectal disease which can not allowed to plug the ultrasound probe in; 4.do not fully understand our protocol;
  • do not aggree our protocol.

结局指标

主要结局

highest VAS scores

时间窗: ask patients in 2 minutes after prostate biopsy

the highest VAS (visual analogue scale) scores during the procedure in one patient. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. VAS is the most common pain scale for quantification of endometriosis-related pain and skin graft donor site-related pain. In detail, it is a 10-point categorical scale pain measurement. The score ranges from 0 to 10, and the no pain is 0, and highest pain is 10.

次要结局

  • Complications(during the procedures and 1 days after the procedure)
  • patients movement(during the transperineal prostate biopsy)
  • main VAS scores(ask patients in 2 minutes after prostate biopsy)

研究者

发起方
Second Military Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

yinghao Sun

Principal Investigator

Second Military Medical University

研究点 (1)

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