MRI Evaluation of Local Anesthesia Administration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Patient reported sensation - 5min
研究概览
简要总结
The purpose of this research is to investigate the utility of using dental-dedicated MRI as a measurement tool to observe and evaluate the administration of local anesthesia in dental patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age 18 or older
- •Health status of American Society of Anesthesiologists (ASA) class 1 or 2
- •Able to provide informed consent
- •Able to appear in person at OMRIC on the days indicated for the study
排除标准
- •ASA class 3 or higher
- •Pregnant patients
- •Taking any medication that would affect pain perception or interact with local anesthetic
- •Allergic/history of adverse reaction to local anesthetic or any component in the local anesthetic
- •Paresthesia in the area of innervation of Cranial Nerve V3
- •Active infection or abscess in the oral and maxillofacial region
- •History of temporomandibular disorder, maximum incisal opening less than 15mm
- •History of recent dental trauma (within the past 6 months)
- •Dental hypersensitivity
- •Claustrophobia and/or conditions of anxiety or motion disorder (for MRI purposes)
- •Metallic, electronic, or magnetic implants or devices classified as MR Unsafe or Conditional by the American College of Radiology
- •Unable to give informed consent
研究组 & 干预措施
ddMRI scanning
The ddMRI will take place after anesthesia administration. The ddMRI will allow researchers to see and measure the distribution of the local anesthetic, as well as the the area of the local anesthetic and the intensity on MRI.
干预措施: ddMRI (Device)
结局指标
主要结局
Patient reported sensation - 5min
时间窗: 5 minutes after the nerve block
Minimum value: No numbness Maximum value: Numb High scores mean a successful outcome for the block.
Patient reported sensation - 1 hour
时间窗: within 1 hour of the nerve block
Minimum value: No numbness Maximum value: Numb High scores mean a successful outcome for the block.
Ability to sense light touch
时间窗: within 1 hour of the nerve block
binary scale. Options are yes or no
Ability to sense pressure
时间窗: within 1 hour of the nerve block
Minimum value: 1.65 Maximum value: 6.65 Low scores mean that the participant can sense more, and that the block was less effective
Ability to sense direction of touch (only if can sense VonFrey fibers)
时间窗: within 1 hour of the nerve block
Patient reports direction of sensation (up/down/right/left). This is scored 5 times per site
Ability to distinguish sharp versus dull (only if can sense VonFrey fibers)
时间窗: within 1 hour of the nerve block
Patient reports sharp versus dull sensation. This is scored 5 times per site
次要结局
未报告次要终点