Femoral Nerve Blockade in Endovenous Laser

Pain Clinical Trial

Official title:

Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475641
• Other study ID #: FEMINE
• Status: Completed
• Phase: N/A
• 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
• 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Thanks to technical advancement open surgery has been replaced By endovenous means.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

Related Conditions & MeSH terms

• Pain
• Varicose Veins

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