The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position in the group Ropivacine-Lidocaine and "sham".
研究概览
简要总结
The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (SPG block) on persistent headache following acute COVID-19 infection.
详细描述
Adult patients with persistent headache following COVID-19 infection will be enrolled in the study. The patients will be randomised into three groups; bilateral SPG-block withto receive local anesthetic (lidocaine + ropivacaine), bilateral SPG-block with placebo (isotone NaCl) or bilateral "sham"-block with placebo (isotone NaCl).
Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the headache in standing position 30 minutes after block in the group Ropicavain-Lidocain and "sham".
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)
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
- •Moderate to severe headache (NRS >= 3) with self reported duration of minimum 6 hours during the past week as well as moderate to severe headache (NRS >= 3) on the day of intervention.
- •Onset of headache during or maximum 4 weeks after PCR-verified COVID-19 infection.
- •Headache must have persisted for at least 4 weeks following COVID-19 diagnosis.
排除标准
- •Patients who cannot cooperate to the study
- •Patients who does not understand or speak Danish
- •Allergy to the drugs used in the study
- •Has taken opioids within 12 hours prior to intervention
- •History of migraine or persistent headache before COVID-19 infection.
- •Active COVID-19 infection (defined by the Danish Goverment regulations, i.e. 48 hours after last symptoms (omitting long term effects) or 7 days after positive COVID-19 test if no symptoms.
结局指标
主要结局
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position in the group Ropivacine-Lidocaine and "sham".
时间窗: 30 minutes after block
Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
次要结局
- Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)(30 minutes and 1 week after block)
- Average pain intensity (0-10 on a numercial rating scale, NRS)(During study period until completion of 1 week follow up)
- Number of patients needing "rescue GSP-block"(At 1 week follow up)
- Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position in all 3 groups.(30 minutes after block)
- Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)(During study period until completion of 1 week follow up)
研究者
Mads Seit Jespersen
MD
University Hospital Bispebjerg and Frederiksberg