The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection

University Hospital Bispebjerg and Frederiksberg

Status and phase

Terminated

Phase 3

Conditions

Sphenopalatine Ganglion Block

Covid19

Persistent Headache Following COVID-19

Headache

Treatments

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

Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)

Procedure: Sphenopalatine Ganglion Block with Local Anesthetic

Study type

Interventional

Funder types

Other

Identifiers

NCT04636034

GSPB-COVID-2020

Details and patient eligibility

About

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.

Full 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".

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.