Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

GCS Ramsay Santé pour l'Enseignement et la Recherche400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

400

Conditions

Superficial Venous Insufficiency

Interventions

use of a device incorporating virtual reality softwareDEVICE

use of a device incorporating virtual reality software

NeuroleptanalgesiaDRUG

Usual neuroleptanalgesic treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Clinique de l'Union

Saint-Jean, France

RECRUITING

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

Villeneuve-d'Ascq, France

RECRUITING

Outcomes

Primary Outcomes

Pain intensity assessed by NRS (numerical rating scale)

The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable).

Time frame: Day 1

Secondary Outcomes

Level of pre-operative anxiety assessed by the patient using the STAI-Y

The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).

Time frame: Day 0

Level of post-operative anxiety assessed by the patient using the STAI-Y

The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).

Time frame: Day 1

treatment administered during the procedure

Nature and quantities of additional sedative treatment administered during the procedure

Time frame: Day 1

Pain intensity assessed by NRS (numerical rating scale)

Time frame: Day 1

Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)

Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).

Time frame: Day 0

Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)

Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).

Central Contacts

Lauranne MATRAY, MD

CONTACT

05 61 37 81 81 dr.lmatray.union@gmail.com

Data from ClinicalTrials.gov

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