Femoral Nerve Blockade in Endovenous Laser

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 Thanks to technical advancement open surgery has been replaced By endovenous means.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.

Official Title
-----------------
Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Femoral nerve blockade
* Procedure: The current standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Great saphenous vein insufficiency CEAP class 2-4 Exclusion Criteria: Neurological diseases Pregnancy CEAP 5-6 BMI>40 Allergy to lidocain

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The current standard anesthesia<br>Standard treatment during procedure | Procedure: The current standard treatment<br>* Tumescent anesthesia.<br>|
| Experimental: Femoral nerve blockade<br>Femoral nerve blockade added to the standard treatment. | Drug: Femoral nerve blockade<br>* The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.<br>Procedure: The current standard treatment<br>* Tumescent anesthesia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain analysed by Numeric Rating Scale during operation. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever. | Peri-procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain analysed by Numeric Rating Scale during application of anesthesia. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever. | Pre-procedural | 
| Pain | Pain analysed by Numeric Rating Scale at 1h after the procedure. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever. | 1h after the procedure | 
| Motoric paresthesias of the femoral nerve | Ability to move knee and ankle at the end of the procedure analysed by Bromage scale. The scale measures motoric functioning of the femoral nerve: 0 = full flexion of ankle and knee possible, 1= knee flexion possible 2= ankle flexion possible, 3= impossible to move either knee or ankle | After the phlebectomies | 
| Motoric paresthesias | Ability to move knee and ankle one hour after the procedure analysed by Bromage scale. The scale measures motoric functioning of the femoral nerve: 0 = full flexion of ankle and knee possible, 1= knee flexion possible 2= ankle flexion possible, 3= impossible to move either knee or ankle | through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, femoral nerve blockade, varicose vein