Femoral Nerve Blockade in Endovenous Laser
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Mar 2017
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2017
CompletedFirst Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 9, 2022
August 1, 2022
2.6 years
October 13, 2017
August 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Pain
Pre-procedural
Pain
1h after the procedure
Motoric paresthesias of the femoral nerve
After the phlebectomies
Motoric paresthesias
through study completion, an average of 1 month
Study Arms (2)
The current standard anesthesia
ACTIVE COMPARATORStandard treatment during procedure
Femoral nerve blockade
EXPERIMENTALFemoral nerve blockade added to the standard treatment.
Interventions
The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.
Tumescent anesthesia.
Eligibility Criteria
You may qualify if:
- Great saphenous vein insufficiency
- CEAP class 2-4
You may not qualify if:
- Neurological diseases
- Pregnancy
- CEAP 5-6
- BMI\>40
- Allergy to lidocain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University Hospital, Finland
Helsinki, Uusimaa, 00029, Finland
Related Publications (1)
Hurmerinta-Kurkijarvi O, Weselius EM, Halmesmaki K, Vikatmaa P, Vikatmaa L, Venermo M. Femoral nerve blockade during endovenous laser ablation of great saphenous vein decreases pain but does not affect the use of opioids during the procedure. J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):921-927. doi: 10.1016/j.jvsv.2023.04.007. Epub 2023 May 2.
PMID: 37142055DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anders Alback, MD,PhD
Head of Depratment
- PRINCIPAL INVESTIGATOR
Karoliina H Halmesmaki, MD, PhD
Head of Venous Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Vascular Surgery
Study Record Dates
First Submitted
October 13, 2017
First Posted
March 23, 2018
Study Start
March 13, 2017
Primary Completion
October 15, 2019
Study Completion
December 31, 2021
Last Updated
August 9, 2022
Record last verified: 2022-08