Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 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 surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.
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, botulinum toxin type A, Botox or any of it's constituents or any other related medication
- •Treatment with medication that can interact with botulinum toxin type A
研究组 & 干预措施
Botulinum Toxin
The patients will be injected with 25 IU of Botulinum Toxin Type A towards the sphenopalatine ganglion in the affected side (ipsilateral to the pain)
干预措施: Botulinum Toxin Type A (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. 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 attacks(12 weeks)
- Number of attacks with trigeminal neuralgia per 4 weeks per patient(12 weeks)
- Number of doses of analgesics per 4 weeks per patient(12 weeks)