Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Pain intensity assessed by NRS (numerical rating scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
usual neuroleptanalgesic treatment
- Group 1: local anaesthesia by tumescence + neuroleptanalgesia
干预措施: Neuroleptanalgesia (Drug)
use of a device incorporating virtual reality software
- Group 2: local anaesthesia by tumescence with virtual reality software
干预措施: use of a device incorporating virtual reality software (Device)
结局指标
主要结局
Pain intensity assessed by NRS (numerical rating scale)
时间窗: 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).
次要结局
- Length of stay in the ICU(Day 1)
- Length of stay in the hospital(Day 1)
- Level of pre-operative anxiety assessed by the patient using the STAI-Y(Day 0)
- Level of post-operative anxiety assessed by the patient using the STAI-Y(Day 1)
- Resumption of current activities(Day 1)
- Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)(Day 1)
- treatment administered during the procedure(Day 1)
- Pain intensity assessed by NRS (numerical rating scale)(Day 1)
- Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)(Day 0)
- Surgery duration(Day 0)