NCT01565512撤回1 期
Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Prevalence of pain/discomfort
研究概览
简要总结
The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.
详细描述
Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age 40 years and above,
- •diagnosis of prostate cancer,
- •electing to undergo robot-assisted radical prostatectomy
排除标准
- •allergy to bupivacaine or amide-type local anesthetics,
- •chronic pain condition,
- •recently or currently on narcotics,
- •genital abnormalities
研究组 & 干预措施
saline injection
Placebo Comparator
saline injection
干预措施: Saline (Drug)
Bupivacaine injection
Active Comparator
penile block with bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Prevalence of pain/discomfort
时间窗: postoperative
次要结局
未报告次要终点
研究者
研究点 (1)
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