Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04636034
Status:
TERMINATED
Last Update Posted:
2022-06-10
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
Study Overview
Official Title:
The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment failure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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".
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: