Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain measured in analog visual scale
研究概览
简要总结
Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before.
The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic grade I - III hemorrhoidal disease
排除标准
- •Chronic liver disease
- •Use of class 3 antiarrythmics
- •Coagulopathy
- •Grade IV hemorrhoidal disease
- •Inflammatory bowel disease
- •Pregnancy
研究组 & 干预措施
Topical anesthesia
Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure
干预措施: Topical 2,5% lidocaine + 2,5% prilocaine gel (Drug)
Placebo
Application of placebo gel into the anal canal before the procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Pain measured in analog visual scale
时间窗: up to 72 hours post procedure
次要结局
- Procedure morbidity(up to 30 days post procedure)