The Effect of Intraurethral Lidocaine Gel in Comparison With Plain Lubricating Gel on Pain Perception During Flexible Cystoscopy: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Pain based on a numeric rating scale
研究概览
简要总结
Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy.
In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 18 - 80 years
- •Given indication for flexible cystoscopy
- •Written informed consent
排除标准
- •Allergy to amid anesthetics
- •Urinary tract infection
- •Use of analgesics in the previous 24 hours and chronic intake of analgesics
- •Presence of a sensory disorder such as or spinal cord injury
- •Indwelling catheter carrier
研究组 & 干预措施
Lidocaine gel, counselling, no monitor
干预措施: Lidocaine gel (Device)
Lidocaine gel, counselling, monitor
干预措施: Monitor (Other)
Lidocaine gel, no counselling, monitor
干预措施: Lidocaine gel (Device)
Lidocaine gel, counselling, monitor
干预措施: Counselling (Other)
Lidocaine gel, counselling, no monitor
干预措施: Counselling (Other)
Lidocaine gel, counselling, no monitor
干预措施: No monitor (Other)
Lidocaine gel, no counselling, monitor
干预措施: No counselling (Other)
Lidocaine gel, no counselling, no monitor
干预措施: No counselling (Other)
Lidocaine gel, no counselling, no monitor
干预措施: No monitor (Other)
Lubricating gel, counselling, monitor
干预措施: Counselling (Other)
Lubricating gel, counselling, monitor
干预措施: Lubricating gel (Device)
Lubricating gel, counselling, no monitor
干预措施: Counselling (Other)
Lubricating gel, counselling, no monitor
干预措施: Lubricating gel (Device)
Lubricating gel, counselling, no monitor
干预措施: No monitor (Other)
Lubricating gel, no counselling, monitor
干预措施: Lubricating gel (Device)
Lubricating gel, no counselling, monitor
干预措施: No counselling (Other)
Lubricating gel, no counselling, no monitor
干预措施: Lubricating gel (Device)
Lubricating gel, no counselling, no monitor
干预措施: No counselling (Other)
Lubricating gel, no counselling, no monitor
干预措施: No monitor (Other)
Lubricating gel, counselling, monitor
干预措施: Monitor (Other)
Lubricating gel, no counselling, monitor
干预措施: Monitor (Other)
Lidocaine gel, no counselling, no monitor
干预措施: Lidocaine gel (Device)
Lidocaine gel, counselling, monitor
干预措施: Lidocaine gel (Device)
Lidocaine gel, no counselling, monitor
干预措施: Monitor (Other)
结局指标
主要结局
Pain based on a numeric rating scale
时间窗: During flexible cystoscopy
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
次要结局
- Pain based on a numeric rating scale(3 days after flexible cystoscopy)
- Pain based on a verbal rating scale(Immediately after flexible cystoscopy)
研究者
Ajet Hyseni
Dr.med.univ.RKS
Luzerner Kantonsspital