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

Phase 3

Terminated

• Conditions: Headache; Persistent Headache Following COVID-19; Covid19; Sphenopalatine Ganglion Block
• Interventions: Procedure: "Sham"-block with Placebo (Isotone NaCl); Procedure: Sphenopalatine Ganglion Block with Local Anesthetic; Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)

• Registration Number: NCT04636034
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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".

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Study Start: 2021-01-12
• Status Verified: 2022-06
• Primary Completion: 2022-06-06
• Study Completion: 2022-06-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Sham"-block with Placebo	"Sham"-block with Placebo (Isotone NaCl)	-
Ropivacaine-Lidocaine	Sphenopalatine Ganglion Block with Local Anesthetic	-
Placebo	Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)	-

Primary Outcome Measures

Name	Time	Method
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".	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 Outcome Measures

Name	Time	Method
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	Pain intensity 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.
Average pain intensity (0-10 on a numercial rating scale, NRS)	During study period until completion of 1 week follow up	The average pain intensity reported during the week following the block as registered by the patient.
Number of patients needing "rescue GSP-block"	At 1 week follow up	If the patient at the 1 week follow up still needs further treatment a "rescue SPG-block" defined as a new SPG-block with "open label" analgetics will be offered.
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	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.
Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)	During study period until completion of 1 week follow up	The worst experienced pain reported during the week following the block as registered by the patient.

Trial Locations

Locations (1)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen; 🇩🇰 Copenhagen, Denmark