Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Not Applicable

Recruiting

• Conditions: Superficial Venous Insufficiency
• Interventions: Device: use of a device incorporating virtual reality software; Drug: Neuroleptanalgesia

• Registration Number: NCT06228365
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

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.

Study Timeline

• Study Start: 2023-11-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
use of a device incorporating virtual reality software	use of a device incorporating virtual reality software	- Group 2: local anaesthesia by tumescence with virtual reality software
usual neuroleptanalgesic treatment	Neuroleptanalgesia	- Group 1: local anaesthesia by tumescence + neuroleptanalgesia

Primary Outcome Measures

Name	Time	Method
Pain intensity assessed by NRS (numerical rating scale)	Day 1	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).

Secondary Outcome Measures

Name	Time	Method
Level of pre-operative anxiety assessed by the patient using the STAI-Y	Day 0	The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).
Level of post-operative anxiety assessed by the patient using the STAI-Y	Day 1	The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).
treatment administered during the procedure	Day 1	Nature and quantities of additional sedative treatment administered during the procedure
Pain intensity assessed by NRS (numerical rating scale)	Day 1	Pain intensity assessed by NRS (numerical rating scale)
Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)	Day 0	Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)	Day 1	Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Surgery duration	Day 0	Assessment of the surgery duration
Length of stay in the ICU	Day 1	Length of stay in the ICU
Length of stay in the hospital	Day 1	Length of stay in the hospital
Resumption of current activities	Day 1	Resumption of current activities measured by: YES or NO

Trial Locations

Locations (1)

Clinique de l'Union; 🇫🇷 Saint-Jean, France