Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Number of Migraine Headaches During Treatment Phase
研究概览
简要总结
Determine the effects of sphenopalatine ganglion (SPG) block in post-stroke headache.
详细描述
The purpose of this study is to determine if sphenopalatine ganglion (SPG) block is a safe and effective treatment for acute post-stroke headache. Current literature lacks randomized controlled studies regarding the efficacy of different treatment modalities for acute post-stroke headache; additionally, there are no evidence-based guidelines for the treatment of acute post-stroke headache. Sphenopalatine ganglion block is a non-invasive procedure where an anesthetic agent is injected into the nares, reaching the SPG to relieve pain and autonomic features. This treatment has been effective in a variety of headache types but to our knowledge has not been studied in acute post-stroke headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18 years or older;
- •hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician;
- •meets at least one of the following International Classification of Headache Disorder-3 (ICHD-3) criteria: 6.1.1.1 (Acute Headache Attributed to Ischemic Stroke), 6.2.1 (Headache attributed to non-traumatic intracerebral hemorrhage), 6.2.2 (Acute headache attributed to non-traumatic subarachnoid hemorrhage); received at least one medication for headache during hospitalization.
排除标准
- •Previous treatment with SPG Block for post-stroke headache
- •history of prophylactic medication use for headache or migraine;
- •pregnant at time of stroke
研究组 & 干预措施
Liquid Lidocaine
The investigational treatment is 1.5 mL of aqueous 2% lidocaine.
干预措施: Liquid Lidocaine (Drug)
Sham Placebo
The placebo arm is 1.5mL of aqueous of saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Number of Migraine Headaches During Treatment Phase
时间窗: 90 days
Evaluate the efficacy of Lidocaine delivered to SPG, based on the use of rescue medication and number of headache in headache diary
次要结局
- Numeric Pain Rating Scale(90 days)
- Adverse effect(90 days)