Clinical trial NCT04636034: The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
Official title: The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Headache
Covid19
Sphenopalatine Ganglion Block
Persistent Headache Following COVID-19
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".

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.

Primary outcomes:
measure: 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".
timeFrame: 30 minutes after block
Secondary outcomes:
measure: Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
timeFrame: 30 minutes and 1 week after block
measure: Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)
timeFrame: During study period until completion of 1 week follow up
measure: Average pain intensity (0-10 on a numercial rating scale, NRS)
timeFrame: During study period until completion of 1 week follow up
measure: Number of patients needing "rescue GSP-block"
timeFrame: At 1 week follow up
measure: 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.
timeFrame: 30 minutes after block
Other outcomes:
measure: Analgesics used daily in the week following the SPG-block
timeFrame: During study period until completion of 1 week follow up
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Study officials:
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Christian S Meyhoff, PhD
role: STUDY_DIRECTOR
References: