Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Last updated: November 25, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Varicose Veins

Deep Vein Thrombosis

Treatment

use of a device incorporating virtual reality software

Neuroleptanalgesia

Clinical Study ID

NCT06228365
2023-A01948-37
  • Ages > 18
  • All Genders

Study Summary

Virtual reality has been shown to reduce the pain experienced during medical procedures.

The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 18 or over, who has read and signed the consent form for participationin the study after a reflection period (approximately 1 hour).

  • Outpatients with superficial venous insufficiency for which a surgical indicationhas been given

  • Patient requiring sedation associated with local anesthesia

Exclusion

Exclusion Criteria:

  • Contraindication to local anesthesia or any of the sedatives used in the protocol

  • Hearing or visual impairment contraindicating use of the virtual reality headset

  • Pregnant or breast-feeding patients

  • Unbalanced epilepsy

  • Patients under court protection, guardianship or curatorship

  • Patients not affiliated to the French social security system

  • Patient unable to understand informed information and/or give written informedconsent: dementia, psychosis, disturbed consciousness, non-French-speaking patient

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: use of a device incorporating virtual reality software
Phase:
Study Start date:
November 20, 2023
Estimated Completion Date:
June 30, 2026

Study Description

The main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.Pain will be assessed on an ENS immediately at the end of the surgical procedure.

Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.

Maximum duration of patient participation in the study = 2 days.

Connect with a study center

  • Clinique de l'Union

    Saint-Jean, 31240
    France

    Site Not Available

  • Clinique de l'Union

    Saint-Jean 2979394, 31240
    France

    Active - Recruiting

  • Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Villeneuve-d'Ascq

    Villeneuve-d'Ascq 6543862, 59650
    France

    Active - Recruiting

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