Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

NCT06228365 | Recruiting

• 1 other identifier: 2023-A01948-37
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Superficial Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1

Secondary Outcomes (10)

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

  Day 0

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

  Day 1

• treatment administered during the procedure

  Day 1

• Pain intensity assessed by NRS (numerical rating scale)

  Day 1

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

  Day 0

Study Arms (2)

usual neuroleptanalgesic treatment

ACTIVE COMPARATOR

\- Group 1: local anaesthesia by tumescence + neuroleptanalgesia

Drug: Neuroleptanalgesia

use of a device incorporating virtual reality software

EXPERIMENTAL

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

Device: use of a device incorporating virtual reality software

Interventions

use of a device incorporating virtual reality software DEVICE

use of a device incorporating virtual reality software

use of a device incorporating virtual reality software

Neuroleptanalgesia DRUG

Usual neuroleptanalgesic treatment

usual neuroleptanalgesic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Vivactis M2Research: collaborator

Study Sites (2)

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

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

Villeneuve-d'Ascq, 59650, France

RECRUITING

MeSH Terms

Interventions

Neuroleptanalgesia

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Lauranne MATRAY, MD

  Clinique de l'Union

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauranne MATRAY, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 14, 2023
• First Posted: January 29, 2024
• Study Start: November 20, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)