Double Blinded Randomized Controlled Trial evaluating the feasibility, safety and efficacy of Femoral Nerve Block for analgesia in patients with varicose veins being treated by Endovenous Laser Ablation of Great Saphenous Vein
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Peri-procedural pain using visual analogue scale (1-10)
研究概览
简要总结
Varicose veins are the dilated and tortuous veins in the subcutaneous tissue of the leg. It affects more than one-third of general population in their lifetime. Minimally invasive treatment strategy using endovenous laser ablation (EVLA) and/or foam sclerotherapy have replaced open surgery throughout the world. This is because of increased safety, efficacy, faster recovery and better cosmetic results. EVLA is normally performed by using local perivenous tumescent anaesthesia (TA). The role of TA is to eliminate pain during the EVLA procedure, as well as protect the surrounding tissues from thermal injury due to laser. However, TA requires multiple punctures along medial aspect of thigh along the course of great saphenous vein (GSV) which may induce pain**.** The intensity of this pain is ‘‘tolerable’’ for most patients, but it may be a ‘‘bad experience’’ for the others. Also, this pain may be intense if venous spasm occurs during catheterization. Administering femoral nerve block under ultrasound guidance (US-FNB) is an option to reduce this discomfort. Feasibility, pain control efficiency and safety of US-FNB has been established in the past, and few studies have also been done using this analgesia technique for EVLA procedure as well. However, there is lack of a robust randomised-placebo controlled trial evaluating the same. Hence, we intend to do a single-centre double blinded randomised placebo-controlled trial to evaluate the feasibility, safety and efficacy of USG guided femoral nerve block for EVLA of GSV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1.C2-6, Ep, As, according to the CEAP classification [clinical, etiologic, anatomical, and pathophysiological (CEAP)]
- •Primary signs and symptoms of truncal(saphenous, accessory, non saphenous) vein incompetence/relux with reflux time of 1 sec or more on Doppler, and diameter of varicose veins more than 3mm and less than 15mm.
排除标准
- •1.Any patient who doesn’t give consent for being included in the study.
- •2.Evidence of peripheral arterial disease 3.Any previous treatment, such as surgery, EVLA, radiofrequency ablation, or FS, for ipsilateral varicosity.
- •4.Lower limb varicosity caused by deep venous thrombosis.
- •Coagulation disorder, pregnancy, lactation, current thrombosis, systemic disease, poor general health.
结局指标
主要结局
Peri-procedural pain using visual analogue scale (1-10)
时间窗: Patient will be assessed immediately after completion of EVLA procedure.
次要结局
- 1. Motor Block assessment(2. Assess for length of patent GSV distal to SFJ)
