Femoral Nerve Blockade in Endovenous Laser
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Femoral nerve blockade
The current standard treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring pain, femoral nerve blockade, varicose vein
Eligibility Criteria
Inclusion Criteria:
- Great saphenous vein insufficiency
- CEAP class 2-4
Exclusion Criteria:
- Neurological diseases
- Pregnancy
- CEAP 5-6
- BMI>40
- Allergy to lidocain
Sites / Locations
- Helsinki University Hospital, Finland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
The current standard anesthesia
Femoral nerve blockade
Arm Description
Standard treatment during procedure
Femoral nerve blockade added to the standard treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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
Full Information
NCT ID
NCT03475641
First Posted
October 13, 2017
Last Updated
August 8, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03475641
Brief Title
Femoral Nerve Blockade in Endovenous Laser
Official Title
Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, femoral nerve blockade, varicose vein
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The current standard anesthesia
Arm Type
Active Comparator
Arm Description
Standard treatment during procedure
Arm Title
Femoral nerve blockade
Arm Type
Experimental
Arm Description
Femoral nerve blockade added to the standard treatment.
Intervention Type
Drug
Intervention Name(s)
Femoral nerve blockade
Intervention Description
The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.
Intervention Type
Procedure
Intervention Name(s)
The current standard treatment
Intervention Description
Tumescent anesthesia.
Primary Outcome Measure Information:
Title
Pain
Description
Pain analysed by Numeric Rating Scale during operation. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever.
Time Frame
Peri-procedural
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
Pre-procedural
Title
Pain
Description
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.
Time Frame
1h after the procedure
Title
Motoric paresthesias of the femoral nerve
Description
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
Time Frame
After the phlebectomies
Title
Motoric paresthesias
Description
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
Time Frame
through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Great saphenous vein insufficiency
CEAP class 2-4
Exclusion Criteria:
Neurological diseases
Pregnancy
CEAP 5-6
BMI>40
Allergy to lidocain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Alback, MD,PhD
Organizational Affiliation
Head of Depratment
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karoliina H Halmesmaki, MD, PhD
Organizational Affiliation
Head of Venous Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital, Finland
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The decision to share the data is made after follow-up
Learn more about this trial
Femoral Nerve Blockade in Endovenous Laser
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