Official Title
The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
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".

Terminated
Headache
COVID19
Sphenopalatine Ganglion Block
Persistent Headache Following COVID-19

Procedure: Sphenopalatine Ganglion Block with Local Anesthetic

Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL

Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)

Block performed with bilaterally inserted q-tips with isotone NaCl

Procedure: "Sham"-block with Placebo (Isotone NaCl)

Block performed with bilaterally inserted q-tips with isotone NaCl. The q-tips are inserted a maximum of 3 cm into the nasopharynx thus not reaching the mucus above the ganglion.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Denmark
Locations

Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, Denmark

Christian S Meyhoff, PhD, Study Director
University Hospital Bispebjerg and Frederiksberg

University Hospital Bispebjerg and Frederiksberg
NCT Number
MeSH Terms
COVID-19
Ganglion Cysts
Synovial Cyst
Headache
Anesthetics
Anesthetics, Local