NCT05778903Unknown不适用
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of LA spread into the PPF
研究概览
简要总结
Ultrasound-guided suprazygomatic maxillary nerve block (SMNB) will be performed in paediatric patients with or without the aid of ultrasound guidance. Magnetic resonance imaging (MRI) is used to visualize the spread of the local anaesthetic (LA) spread after suprazygomatic injection and to verify LA contact with the maxillary nerve in the pterygopalatine fossa (PPF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patients scheduled for cleft palate (CP) surgery with SMNB as part of their perioperative pain treatment
- •American Society of Anesthesiologists physical status 1 - 2
- •Age 10 to 24 months
- •Given informed written consent by legal guardian
排除标准
- •American Society of Anesthesiologists physical status > 2
- •Patients with cranial deformation
- •Patients with concomitant medical treatments or medical conditions interfering with peripheral nerve block treatment
- •Patients with concomitant medical treatments or medical conditions interfering with MRI
- •Patients that are allergic to bupivacaine or other local anaesthetic agents.
结局指标
主要结局
Rate of LA spread into the PPF
时间窗: day one - within an hour after intervention (peripheral nerve block)
Local anesthetic spread to the maxillaris nerve in the pterygopalatine fossa detected by MRI (binary outcome)
次要结局
- Postoperative analgesic consumption(day one and day two)
- MRI time(day one)
- Needle depth(day one - immediately after intervention (peripheral nerve block))
- Side effects and adverse events(day one)
- Rate of hematoma(day one - within an hour after intervention (peripheral nerve block))
- Rate of LA spread to other anatomical areas and structures(day one - within an hour after intervention (peripheral nerve block))
- Superior-inferior needle angle(day one - immediately after intervention (peripheral nerve block))
- Anterior-posterior needle angle(day one - immediately after intervention (peripheral nerve block))
研究者
Axel R. Sauter
Principal Investigator
Oslo University Hospital
研究点 (2)
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