Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

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.

Inclusion criteria

• Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour).
• Outpatients with superficial venous insufficiency for which a surgical indication has been given
• Patient requiring sedation associated with local anesthesia

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 informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient