Femoral Nerve Blockade in Endovenous Laser

Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: The current standard treatment; Drug: Femoral nerve blockade

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Thanks to technical advancement open surgery has been replaced By endovenous means.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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Hospital, Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Great saphenous vein insufficiency
• CEAP class 2-4

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Chair: Anders Alback, MD,PhD, Head of Depratment; Principal Investigator: Karoliina H Halmesmaki, MD, PhD, Head of Venous Department

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pain; varicose vein; femoral nerve blockade
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: FEMINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The decision to share the data is made after follow-up

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No