The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Headache
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- 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".
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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".
Investigators
Mads Seit Jespersen
MD
University Hospital Bispebjerg and Frederiksberg
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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".
Time Frame: 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.
Secondary Outcomes
- 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)