The Impact of Nerve Cross Section Area on Sensory Block Onset. A Prospective, Monocentric Crossover Study on Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Correlation between nerve cross-section and time to complete sensory block of a nerve
研究概览
简要总结
The study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation.
In the case of discovering a correlation, this could be translated into clinical practice, where a more tailored and individualized approach to performing peripheral nerve blocks would be possible, thus lowering the risks of adverse events occurring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I - II, both sexes
- •≥ 18 years old
- •< 65 years old
- •Written informed consent as documented by signature
排除标准
- •Known allergy or hypersensitivity to a study drug or class of drug.
- •Severe coagulopathy.
- •History of alcohol abuse or the intake of psychotropic drugs.
- •Pregnancy.
- •Infection at the injection site or a systemic infection.
- •Fever of unknown origin.
- •Motor or sensory abnormalities in the arm.
- •Previous enrollment into the current study
结局指标
主要结局
Correlation between nerve cross-section and time to complete sensory block of a nerve
时间窗: Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes
Correlation between the nerve cross-section in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the moment the investigator starts injecting the local anesthetic (LA) around the respective nerves to complete sensory loss in the innervation area of the blocked nerve, assessed by response to light touch, pinprick and cold sensation. This correlation will be expressed in min/ mm2.
次要结局
- Correlation between nerve cross-section and the duration of sensory nerve block(The evaluation of the duration of block will start one hour after the determined complete sensory loss and will be tested every 10 minutes until complete resolution of the sensory block. Expected time frame: 10-300 minutes)
- Correlation between the nerve cross-section and duration of motor nerve block(The evaluation of the duration of sensory block will start one hour after the determined complete motor loss and will be tested every 10 minutes until complete resolution of the motor block. Expected time frame: 10-300min)
- Correlation between nerve cross-section and time to complete motor block of a nerve(Motor evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete motor block. Expected time frame: 10-100 minutes)
研究者
Jose Aguirre
PD Dr. med.
Balgrist University Hospital