Femoral Nerve Blockade in Endovenous Laser

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: The current standard treatment; Drug: Femoral nerve blockade

• Registration Number: NCT03475641
• Lead Sponsor: Helsinki University Central Hospital

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Thanks to technical advancement open surgery has been replaced By endovenous means.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

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-23
• Primary Completion: 2019-10-15
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Great saphenous vein insufficiency
• CEAP class 2-4

Exclusion Criteria

• Neurological diseases
• Pregnancy
• CEAP 5-6
• BMI>40
• Allergy to lidocain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The current standard anesthesia	The current standard treatment	Standard treatment during procedure
Femoral nerve blockade	Femoral nerve blockade	Femoral nerve blockade added to the standard treatment.
Femoral nerve blockade	The current standard treatment	Femoral nerve blockade added to the standard treatment.

Primary Outcome Measures

Name	Time	Method
Pain	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.

Secondary Outcome Measures

Name	Time	Method
Pain	1h after the procedure	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.
Motoric paresthesias of the femoral nerve	After the phlebectomies	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
Motoric paresthesias	through study completion, an average of 1 month	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

Trial Locations

Locations (1)

Helsinki University Hospital, Finland; 🇫🇮 Helsinki, Uusimaa, Finland