Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- successful detection of the epidural space
研究概览
简要总结
Pediatric epidural anesthesia has emerged as a safe and effective regional anesthesia technique for providing intraoperative and postoperative analgesia in thoracic and abdominal surgery. The loss of resistance technique is the gold standard for the placement of the epidural.
The VPC (visual pressure control) syringes developed by PAJUNK enable direct visualization of the introduction of the needle into the epidural space.
详细描述
This trial is a non blinded, pilot study. A minimum of 15 children between the ages of 0 and 16 who require surgery that may benefit from epidural anesthesia will be enrolled.
The number of attempts, the complications (dural and vascular punctures, neurological complications) and the degree of satisfaction of the operator measured by a 7-point likert scale will be studied as secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged from 0 to 16y
- •surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia
排除标准
- •parental refusal
- •allergy to local anesthetics
- •coagulation disorders
- •spine abnormalities
结局指标
主要结局
successful detection of the epidural space
时间窗: 24 hours
The primary objective will be successful detection of the epidural space by visualization of dural displacement upon injection of local anesthetic with real-time ultrasound and/or absence of pain at the incision established by the absence of more than 10% elevation in heart rate.
次要结局
- Number of participants with vascular puncture(24 hours)
- Number of participants with nerve damage(Month 3)
- Number of participants with dural puncture(24 hours)
- Operator's satisfaction questionnaire(24 hours)
研究者
Emmanuel Noel
Deputy head of anesthesiology department
Centre Hospitalier Universitaire de Tivoli