Clinical trial NCT06228365: Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation
Official title: Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Superficial Venous Insufficiency
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Vivactis M2Research
First posted: 2024-01-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.

Maximum duration of patient participation in the study = 2 days.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity assessed by NRS (numerical rating scale)
timeFrame: Day 1
Secondary outcomes:
measure: Level of pre-operative anxiety assessed by the patient using the STAI-Y
timeFrame: Day 0
measure: Level of post-operative anxiety assessed by the patient using the STAI-Y
timeFrame: Day 1
measure: treatment administered during the procedure
timeFrame: Day 1
measure: Pain intensity assessed by NRS (numerical rating scale)
timeFrame: Day 1
measure: Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)
timeFrame: Day 0
measure: Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)
timeFrame: Day 1
measure: Surgery duration
timeFrame: Day 0
measure: Length of stay in the ICU
timeFrame: Day 1
measure: Length of stay in the hospital
timeFrame: Day 1
measure: Resumption of current activities
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
affiliation: Clinique de l'Union
name: Lauranne MATRAY, MD
role: PRINCIPAL_INVESTIGATOR
References: