Femoral Nerve Blockade in Endovenous Laser

NCT ID: NCT03475641

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2021-12-31

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Thanks to technical advancement open surgery has been replaced By endovenous means.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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The current standard anesthesia

Standard treatment during procedure

Group Type: ACTIVE_COMPARATOR

The current standard treatment

Intervention Type: PROCEDURE

Tumescent anesthesia.

Femoral nerve blockade

Femoral nerve blockade added to the standard treatment.

Group Type: EXPERIMENTAL

Femoral nerve blockade

Intervention Type: DRUG

The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.

The current standard treatment

Intervention Type: PROCEDURE

Tumescent anesthesia.

Interventions

Femoral nerve blockade

The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.

Intervention Type: DRUG

The current standard treatment

Tumescent anesthesia.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maarit Venermo

Professor in Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Alback, MD,PhD

Role: STUDY_CHAIR

Head of Depratment

Karoliina H Halmesmaki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Venous Department

Locations

Helsinki University Hospital, Finland

Helsinki, Uusimaa, Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 37142055 (View on PubMed)

Other Identifiers

FEMINE

Identifier Type: -

Identifier Source: org_study_id