Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
详细描述
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.
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
- Double (Participant, Care Provider)
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
- •Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
- •Age of 18 or above
排除标准
- •age under
- •Patients unable to understand an informed consent.
- •Emergency operations
- •Pregnant women.
- •Patients with acute perianal infection.
- •Patients allergic to any component of the local anesthetic
研究组 & 干预措施
Placebo
Placebo 40 mL Saline 0.9%
干预措施: Placebo 40 mL Saline 0.9% (Drug)
Ropivacain
40 mL Ropivacain 0.5%
干预措施: 40 mL Ropivacain 0.5% (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 24 hours post-surgery
Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced)
次要结局
- Quality of Life assessed by questionnaire(2 weeks post-surgery)