Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified. Currently endovenous thermal ablation is a treatment of choice for varicose veins. At the outpatient setting, however, treating both limbs at the same time may be painful to the patient especially, if simultaneous phlebectomies are performed.
The study aims to evaluate, if femoral nerve blockade can significantly decrease pain during the procedure without prolonging the stay in the hospital.
详细描述
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified.
Thanks to technical advancement open surgery has been replaced By endovenous means. Currently endovenous thermal ablation is a golden standard for main trunk disease. For efficient patient and procedure flow majority of thermal ablations are performed at the outpatient setting. However, if patient is suffering from significant varicose veins, treating both legs, may be unpleasant to the patient.
Aim of the study is, whether addition of femoral nerve blockade to the tumescent anesthesia can decrease pain during the procedure without prolonging the stay in the hospital.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Great saphenous vein insufficiency
- •CEAP class 2-4
排除标准
- •Neurological diseases
- •Pregnancy
- •Allergy to lidocain
研究组 & 干预措施
Femoral nerve blockade
Femoral nerve blockade added to the standard treatment.
干预措施: The current standard treatment (Procedure)
The current standard anesthesia
Standard treatment during procedure
干预措施: The current standard treatment (Procedure)
Femoral nerve blockade
Femoral nerve blockade added to the standard treatment.
干预措施: Femoral nerve blockade (Drug)
结局指标
主要结局
Pain
时间窗: Peri-procedural
Pain analysed by Numeric Rating Scale during operation. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever.
次要结局
- Pain(1h after the procedure)
- Motoric paresthesias of the femoral nerve(After the phlebectomies)
- Motoric paresthesias(through study completion, an average of 1 month)
研究者
Maarit Venermo
Professor in Vascular Surgery
Helsinki University Central Hospital