The Effect of Sphenopalatine Ganglion Block Versus Placebo on Headache the Day After Participation in Metal Festival: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Headache Pain Intensity 10 minutes after SPGB
研究概览
简要总结
The purpose of this study is to evaluate the effect of sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell.
详细描述
The purpose of this study is to evaluate the effect of sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell.
Headache is one of the most commonly reported symptoms following heavy alcohol consumption and is expected to be particularly pronounced after exposure to noisy environments. Headaches can have negative consequences such as reduced cognitive function and absence from school or work despite treatment with basic pain medication.
A Danish study has previously shown that SPG block is effective against some of the most severe types of headache (e.g., post-dural puncture headache and migraine), but its potential after participation in a music festival has not yet been explored.
The mechanism and pathophysiology behind headache and veisalgia after significant alcohol intake are not well understood but are believed to be multifactorial. Headache following alcohol consumption is thought to arise from a dysreflexia that leads to cerebral vasodilation, which causes the headache. This cerebral vasodilation is mediated by the parasympathetic nervous system, partly via neurons in the sphenopalatine ganglion (SPG), which is located at the back of the nasal cavity.
Treatment that inhibits this vasodilation by blocking the SPG is still relatively new in Denmark, but a Danish study has demonstrated its effect on post-dural puncture headache, where it was found to potentially cure more than half of the cases, thus sparing patients further invasive treatment. However, the study concluded that much of the block's effect could not necessarily be attributed to the local anesthetic but might instead be due to mechanical stimulation of the ganglion.
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Screening Criteria:
- •Age ≥ 18 years
- •Expected to consume a large amount of alcohol at the metal festival Copenhell
- •Expected to be able to cooperate during block administration
- •No known history of migraine, chronic headache, or allergy to substances used in the study
- •Able to understand and speak Danish
- •Inclusion Criteria:
- •Meets screening criteria and is present on the day of intervention
- •Moderate to severe headache (defined as ≥ 3 on a 0-10 VAS) on the day of intervention
排除标准
- •Intake of alcohol or other intoxicating substances after waking up on the day of intervention.
结局指标
主要结局
Headache Pain Intensity 10 minutes after SPGB
时间窗: 10 minutes following block
Pain intensity (0-100 mm on a visual analog scale, VAS) of the headache in a standing position 10 minutes after administration of the block in the Ropivacaine-Lidocaine group and the Sham group. Pain intensity is measured as the worst pain experienced after the person has been standing for 30 seconds, or as the worst pain during the attempt to stand if the test must be aborted.
次要结局
- Pain score below 30mm (VAS)(10 minutes following block)
- Difference in headache pain intensity in standing position(10 minutes following block)
- Severity of veisalgia(10 minutes following block)
- Difference in veisalgia severity(10 minutes following block)
研究者
Christian S. Meyhoff
MD, PhD, Professor
University Hospital Bispebjerg and Frederiksberg