Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed and written consent
- •Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
- •Unsatisfactory effect of pharmacological treatment
排除标准
- •Microvascular decompression is seen as a better alternative
- •Heart or lung disease
- •Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
- •Psychiatric illness that hinders participation in the study
- •Known pregnancy or breast feeding
- •Inadequate use of contraceptives
- •Overuse or abuse of opioids
- •Abuse of medications, narcotics or alcohol
- •Anomalies which hinder or impede the used method of injection
- •Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin
研究组 & 干预措施
Glycerol injection
The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.
干预措施: Glycerol (Drug)
结局指标
主要结局
Number of adverse events
时间窗: For the follow-up period of 12 weeks
Number of adverse events and number of participants with adverse events after glycerol injection in the trigeminal ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.
次要结局
- Number of attacks with trigeminal neuralgia(12 weeks)
- Intensity of the trigeminal neuralgia attacks assessed by questionnaire(12 weeks)
- Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale(12 weeks)
- Number of doses of common analgesics(12 weeks)