Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in pain level
研究概览
简要总结
The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.
详细描述
Epididymitis or orchiepididymitis is an acute disease causing pain and discomfort.
our hypothesis is that local cooling of the affected testis or epididymis may relieve the pain and reduce the analgetics consumption In order to examine this hypothesis we will recruit adult patients with epididymitis or orchiepididymitis and will randomize these patients to two arms.
One arm will receive every 8 hours a brick cooled for at least 2 hours in -20(celsius) for local use on the affected hemiscrotum, while the second arm will receive a brick in room temperature.
Pain level will be estimated one hour following the application of the brick using visual analogue pain score. Patient will receive analgetics according to a predefined escalating protocol.
Pain level and analgetics consumption will be compared between the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 18-99 years
- •Acute epididymitis or acute orchiepididymitis
排除标准
- •Patient unable to informed consent
- •Suspicion of testicular malignancy
研究组 & 干预措施
Local hypothermia
Local application of a brick cooled to -20(celsius)
干预措施: Local hypothermia (Other)
Control
Local application of a brick in room temperature
干预措施: Control (Other)
结局指标
主要结局
change in pain level
时间窗: pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
intervention and measurement will be examined three times a day following brick/cooled brick
次要结局
- Total consumption in grams of protocol analgetics(analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks)
研究者
Dan Leibovici
professor
Kaplan Medical Center