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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03475641
Other study ID # FEMINE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2017
Est. completion date December 31, 2021

Study information

Verified date August 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 Thanks to technical advancement open surgery has been replaced By endovenous means.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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 31, 2021
Est. primary completion date October 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Femoral nerve blockade
The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.
Procedure:
The current standard treatment
Tumescent anesthesia.

Locations

Country Name City State
Finland Helsinki University Hospital, Finland Helsinki Uusimaa

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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