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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl); Block performed with bilaterally inserted q-tips with isotone NaCl
Experimental: Ropivacaine-Lidocaine	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
Sham Comparator: "Sham"-block with Placebo	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Investigators: Study Director: Christian S Meyhoff, PhD, University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; COVID-19; Headache; Ganglion Cysts; Synovial Cyst; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: GSPB-COVID-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No