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Recruiting NCT06228365

Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

No phase Interventional Superficial Venous Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: use of a device incorporating virtual reality software, Neuroleptanalgesia.
Who it may be relevant to
Registry conditions: Superficial Venous Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device use of a device incorporating virtual reality software
    use of a device incorporating virtual reality software
  • Drug Neuroleptanalgesia
    Usual neuroleptanalgesic treatment

Primary outcome measures

  • Pain intensity assessed by NRS (numerical rating scale) [Time frame: Day 1]
Secondary outcome measures (10)
  • Level of pre-operative anxiety assessed by the patient using the STAI-Y [Time frame: Day 0]
  • Level of post-operative anxiety assessed by the patient using the STAI-Y [Time frame: Day 1]
  • treatment administered during the procedure [Time frame: Day 1]
  • Pain intensity assessed by NRS (numerical rating scale) [Time frame: Day 1]
  • Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale) [Time frame: Day 0]
  • Overall patient satisfaction day 1 assessed by NRS (numerical rating scale) [Time frame: Day 1]
  • Surgery duration [Time frame: Day 0]
  • Length of stay in the ICU [Time frame: Day 1]
  • Length of stay in the hospital [Time frame: Day 1]
  • Resumption of current activities [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 2 centers
  • Clinique de l'Union — Saint-Jean
  • Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Ville — Villeneuve-d'Ascq

Identifiers

NCT: NCT06228365 · 2023-A01948-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗