A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 8
- 主要终点
- Change in the proportion of patients experiencing significant pain
研究概览
简要总结
The purpose of this study is to look whether using local anesthesia during a transperineal prostate biopsy, while put to sleep by IV sedation, helps reduce the number of people who feel significant pain in the recovery room. The researchers will also look at how local anesthesia affects the amount of pain medication used, how quickly people can go home after the biopsy, and how well they recover after leaving the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Local anesthesia versus no local anesthesia during transperineal biopsy, while the patient is under IV sedation:
- •Patients scheduled for transperineal prostate biopsy at the JRSC or Monmouth.
- •Standardization of a periprocedural pathway versus usual care for focal gland ablation:
- •Patients scheduled for a partial prostate gland ablation procedure at the JRSC.
排除标准
- •Local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under IV sedation:
- •Standardization of a periprocedural pathway versus usual care for focal gland ablation:
研究组 & 干预措施
No Local anesthesia
No local anesthesia during transperineal biopsy under IV sedation
干预措施: Prostate Biopsy (Procedure)
Local anesthesia
Local anesthesia during transperineal biopsy under IV sedation
干预措施: Prostate Biopsy (Procedure)
Local anesthesia
Local anesthesia during transperineal biopsy under IV sedation
干预措施: Local anesthesia (Drug)
结局指标
主要结局
Change in the proportion of patients experiencing significant pain
时间窗: up to 1 day
defined as at least one pain score ≥ 5 on a 0 - 10 scale in the post anesthesia care unit (PACU)
次要结局
未报告次要终点