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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.
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Thanks to technical advancement open surgery has been replaced By endovenous means.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The current standard anesthesia | Active Comparator | Standard treatment during procedure |
|
| Femoral nerve blockade | Experimental | Femoral nerve blockade added to the standard treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral nerve blockade | Drug | The femoral nerve blockade with lidocain is combined to the tumescent anesthesia. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Alback, MD,PhD | Head of Depratment | Study Chair |
| Karoliina H Halmesmaki, MD, PhD | Head of Venous Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital, Finland | Helsinki | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142055 | Derived | 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. |
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The decision to share the data is made after follow-up
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| ID | Term |
|---|---|
| D010146 | Pain |
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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| The current standard treatment | Procedure | Tumescent anesthesia. |
|
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 |
| D002318 | Cardiovascular Diseases |