Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation (CIMES)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Superficial Venous Insufficiency

Treatments: Drug: Neuroleptanalgesia; Device: use of a device incorporating virtual reality software

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06228365

2023-A01948-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

usual neuroleptanalgesic treatment

Active Comparator group

Description:

\- Group 1: local anaesthesia by tumescence + neuroleptanalgesia

Treatment:

Drug: Neuroleptanalgesia

use of a device incorporating virtual reality software

Experimental group

Description:

\- Group 2: local anaesthesia by tumescence with virtual reality software

Treatment:

Device: use of a device incorporating virtual reality software