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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04636034
• Other study ID #: GSPB-COVID-2020
• Status: Terminated
• Phase: Phase 3
• Start date: January 12, 2021
• Est. completion date: June 6, 2022

Study information

• Verified date: June 2022
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Ganglion Cysts
• Headache
• Persistent Headache Following COVID-19
• Sphenopalatine Ganglion Block

Intervention

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
• Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl
• "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.

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analgesics used daily in the week following the SPG-block	The use of analgesics during the week following the block as registered by the patient and the patient file.	During study period until completion of 1 week follow up
Primary	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".	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.	30 minutes after block
Secondary	Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)	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.	30 minutes and 1 week after block
Secondary	Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)	The worst experienced pain reported during the week following the block as registered by the patient.	During study period until completion of 1 week follow up
Secondary	Average pain intensity (0-10 on a numercial rating scale, NRS)	The average pain intensity reported during the week following the block as registered by the patient.	During study period until completion of 1 week follow up
Secondary	Number of patients needing "rescue GSP-block"	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.	At 1 week follow up
Secondary	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.	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.	30 minutes after block