Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.
研究概览
简要总结
Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.
40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.
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
- Double (Participant, Investigator)
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
- •Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine
- •Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.
- •Pain must be reported as at least moderate pain level at time of injections
排除标准
- •A subject is ineligible to participate in this study if he/she satisfies any of the following criteria:
- •Subjects who have received greater occipital nerve blocks in the past
- •Subjects who in their own or the investigator's opinion are unable to describe their symptoms
- •Subjects who are pregnant or lactating
研究组 & 干预措施
Lidocaine/Bupivicaine
干预措施: 0.5% bupivicaine and 2% lidocaine (Drug)
saline
matching volume of saline injected
干预措施: Saline placebo (Drug)
结局指标
主要结局
Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.
时间窗: 30 minutes
次要结局
- Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;(30 minutes)
- Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.(30 minutes)
- Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;(30 minutes)