A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Participants Who Achieve Freedom From Headache
研究概览
简要总结
This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only enrolled if they fail first line therapy with metoclopramide.
详细描述
The investigators are testing the following hypothesis:
In a population of patients who present to an ED with acute migraine and have been treated with parenteral metoclopramide unsuccessfully, bilateral greater occipital nerve blocks with bupivicaine will provide greater rates of short-term and sustained headache freedom than bupivacaine injected intradermally.
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, Outcomes Assessor)
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
- •ED patient with acute migraine or probable migraine
- •Fail first line therapy with metoclopramide
排除标准
- •Can't obtain consent
- •Concern for secondary headache
- •Skull defect
- •Propensity for bleeding
- •Overlying infection
- •Pregnancy
- •Allergy, intolerance study medication
研究组 & 干预措施
Greater occipital nerve block
Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique
干预措施: Greater occipital nerve block (Procedure)
Sham
Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Number of Participants Who Achieve Freedom From Headache
时间窗: 30 minutes
Pain assessed using a standard ordinal headache intensity scale, in which subjects describe their headache as "severe", "moderate", "mild", or "none". Those with headache level = none, experience freedom from headache.
次要结局
- Sustained Headache Relief(48 hours)
- Would Want the Same Treatment Again During a Subsequent Migraine(48 hours)
研究者
Benjamin W. Friedman, MD
PI
Montefiore Medical Center