UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
研究概览
简要总结
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.
详细描述
Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.
SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.
Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.
With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.
We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.
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 blind study
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
- •Age 18 years or more at time of consent
- •Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
- •Ability to provide consent for the research study
- •Exclusion Criteria
- •Pregnant or breast feeding within 4 weeks of enrollment
- •Inability to communicate with the study team
- •Patients who cannot read and understand English
- •Deemed unsuitable for enrollment in study by the investigator
- •Allergy to local anesthetics or saline
排除标准
- 未提供
研究组 & 干预措施
Placebo (saline)
Participants will receive SPG blocks with placebo (saline)
干预措施: Placebo (Drug)
Bupivacaine
Participants will receive SPG blocks with bupivacaine
干预措施: Bupivacaine (Drug)
Ropivacaine
Participants will receive SPG blocks with ropivacaine
干预措施: Ropivacaine (Drug)
Lidocaine
Participants will receive SPG blocks with lidocaine.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
时间窗: 8 months
Reduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation
次要结局
未报告次要终点