Skip to main content
OpenTrials
Completed

NCT Number: NCT03475641

Femoral Nerve Blockade in Endovenous Laser

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Cardiovascular Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Varicose Veins Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Finland

Helsinki, Uusimaa, 00029, Finland

About this study

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Thanks to technical advancement open surgery has been replaced By endovenous means.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Great saphenous vein insufficiency
  • CEAP class 2-4

Exclusion criteria

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

Treatment and study plan

Femoral nerve blockade

Drug

The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.

The current standard treatment

Procedure

Tumescent anesthesia.

Primary outcomes

  1. Pain

    Time frame: 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 outcomes

  1. Pain

    Time frame: Pre-procedural

    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.

  2. Pain

    Time frame: 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.

  3. Motoric paresthesias of the femoral nerve

    Time frame: 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

  4. Motoric paresthesias

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Mar 23, 2018
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.