Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Clinique de l'Union
RECRUITING
Saint-jean
Contact Information
Primary
Lauranne MATRAY, MD
dr.lmatray.union@gmail.com
05 61 37 81 81
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 400
Treatments
Active_comparator: usual neuroleptanalgesic treatment
\- Group 1: local anaesthesia by tumescence + neuroleptanalgesia
Experimental: use of a device incorporating virtual reality software
\- Group 2: local anaesthesia by tumescence with virtual reality software
Related Therapeutic Areas
Sponsors
Leads: GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators: Vivactis M2Research