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

Phase 3TerminatedNCT04636034

University Hospital Bispebjerg and Frederiksberg18 enrolled

Overview

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".

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Headache Covid19 Sphenopalatine Ganglion Block Persistent Headache Following COVID-19

Interventions

Sphenopalatine Ganglion Block with Local AnestheticPROCEDURE

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)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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 30 minutes after block

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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