NCT06228365

Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Superficial Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	use of a device incorporating virtual reality software	use of a device incorporating virtual reality software
DRUG	Neuroleptanalgesia	Usual neuroleptanalgesic treatment

Timeline

• Start date: 2023-11-20
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2024-01-29
• Last updated: 2025-12-03

Locations

2 sites across 1 country: France