Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- 50% decrease in migraine severity
研究概览
简要总结
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.
详细描述
The greater occipital nerve (GON), which derives most of its fibers from the C2 dorsal root, is the primary sensory nerve of the occipital region. The response to GON blockade was not simply dependent on the direct local anesthetic effect of the injection . The mechanism of action might have been via changes in brain nociceptive pathways. Another possible explanation for these findings is, therefore, that GON injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect . Neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic migraine headache according to International Headache Society Classification Criteria
- •Patients who are not using any prophylacting agent
排除标准
- •patients given similar treatments before
- •pregnant women
- •hereditary diseases causing bleeding
- •patients who have intracranial tumor or operation in posterior fossa
- •allergic reactions to local anesthetics.
研究组 & 干预措施
drug: bupivacaine
Placebo comparator: bupivacaine first 3 months 0.5% 1 cc bupivacaine diluated with 1.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
干预措施: bupivacaine (Drug)
placebo
first 3 months 2.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
干预措施: saline (Drug)
结局指标
主要结局
50% decrease in migraine severity
时间窗: 6 months
次要结局
未报告次要终点
研究者
Levent E. Inan
Professor
Bozok University