A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 0-10 Pain Score
研究概览
简要总结
We are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. This is a randomized, double-blind, double dummy study. The greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double dummy design with IV placebo and placebo nerve block
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
- •Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.
排除标准
- •Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
研究组 & 干预措施
Greater Occipital Nerve Block
Bilateral greater occipital nerve block with bupivacaine 0.5%
- Normal saline IV
干预措施: Greater occipital nerve block with bupivacaine (Procedure)
Metoclopramide
Metoclopramide 10mg IV
- Bilateral greater occipital nerve block with normal saline
干预措施: Metoclopramide (Drug)
结局指标
主要结局
0-10 Pain Score
时间窗: one hour
Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour
次要结局
- Sustained Headache Freedom(48 hours)
- Sustained Headache Relief(48 hours)
研究者
Benjamin W. Friedman, MD
Professor
Montefiore Medical Center