Effects of Anesthetic Blockades on Pain Modulation in Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in the number of days with moderate/intense migraine
研究概览
简要总结
Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chronic migraine
排除标准
- •Other primary headaches
- •Other secondary headaches
- •Co-morbid medical diseases
研究组 & 干预措施
Anesthetic blockades with bupivacaine
Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5%
干预措施: Anesthetic blockades with bupivacaine (Drug)
Isotonic saline injection
Patients will receive a bilateral occipital injection with isotonic saline
干预措施: Isotonic saline injection (Drug)
结局指标
主要结局
Changes in the number of days with moderate/intense migraine
时间窗: Baseline (1 week before) and 1 week after intervention
A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10)
次要结局
- Changes in pressure pain thresholds(Baseline, 1 hour after and 1 week after intervention)
- Changes in the number of days with mild/moderate migraine(Baseline (1 week before) and 1 week after intervention)
- Changes in the number of symptomatic medication drugs(Baseline (1 week before) and 1 week after intervention)
研究者
César Fernández-de-las-Peñas
Proffesor
Universidad Rey Juan Carlos