A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number of participants demonstrating sustained headache relief
研究概览
简要总结
The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are:
- Does a high dose (3ml) give more relief than a low dose (1ml)?
- Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.
Researchers will compare dosage and administration to see how symptoms are reduced.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Present to ED for management of headache
- •Headache is moderate or severe in intensity
排除标准
- •Allergy to bupivacaine
- •Nasal or sinus surgery
研究组 & 干预措施
Low dose with bilateral administration
Low dose (1ml) with bilateral administration of bupivacaine
干预措施: angiocatheter (Device)
High dose with unilateral administration
High dose (3ml) with unilateral administration of bupivacaine
干预措施: Bupivacaine (Drug)
High dose with unilateral administration
High dose (3ml) with unilateral administration of bupivacaine
干预措施: angiocatheter (Device)
High dose with bilateral administration
High dose (3ml) with bilateral administration of bupivacaine
干预措施: Bupivacaine (Drug)
High dose with bilateral administration
High dose (3ml) with bilateral administration of bupivacaine
干预措施: angiocatheter (Device)
Low dose with unilateral administration
Low dose (1ml) with unilateral administration of bupivacaine
干预措施: Bupivacaine (Drug)
Low dose with unilateral administration
Low dose (1ml) with unilateral administration of bupivacaine
干预措施: angiocatheter (Device)
Low dose with bilateral administration
Low dose (1ml) with bilateral administration of bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Number of participants demonstrating sustained headache relief
时间窗: 48 hours
A standard ordinal headache intensity scale will be used for participants to describe their headache as either "severe", "moderate", "mild", or "none". The number of participants who are able to achieve a headache level of "mild" or "none" in the ED within 30 minutes of procedure/medication administration and without requiring additional analgesic medication, and not relapsing to a headache level worse than "mild" during the 48 hours after medication administration, will be determined
次要结局
- Number of participants demonstrating satisfaction with the procedure/medication(48 hours)