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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine-Lidocaine | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| "Sham"-block with Placebo | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine Ganglion Block with Local Anesthetic | Procedure | Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian S Meyhoff, PhD | University Hospital Bispebjerg and Frederiksberg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg and Frederiksberg Hospital, University of Copenhagen | Copenhagen | 2400 | Denmark |
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| Sphenopalatine Ganglion Block with Placebo (Isotone NaCl) | Procedure | Block performed with bilaterally inserted q-tips with isotone NaCl |
|
| "Sham"-block with Placebo (Isotone NaCl) | Procedure | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D006261 | Headache |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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