HeadachePhase 3NCT04636034
The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
A Phase 3 study testing Sphenopalatine Ganglion Block with Local Anesthetic in people with Headache and Covid19, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Covid19, Sphenopalatine Ganglion Block
- What is being tested?
- Sphenopalatine Ganglion Block with Local Anesthetic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jan 2021to 6 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, 2400
About this study
Official title: 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.
Read the 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".
- Being tested
- Sphenopalatine Ganglion Block with Local Anesthetic, Sphenopalatine Ganglion Block with Placebo (Isotone NaCl), "Sham"-block with Placebo (Isotone NaCl)
- Medical subject headings
- Headache, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion Block with Local AnestheticProcedure or surgery
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 or surgery
Block performed with bilaterally inserted q-tips with isotone NaCl
"Sham"-block with Placebo (Isotone NaCl)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine-Lidocaine | Experimental | Not described Receives: Procedure: Sphenopalatine Ganglion Block with Local Anesthetic |
| Placebo | Placebo comparator | Not described Receives: Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl) |
| "Sham"-block with Placebo | Sham comparator | Not described Receives: Procedure: "Sham"-block with Placebo (Isotone NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after block
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start12 Jan 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Why it stopped: Recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian S Meyhoff, PhD, Study director, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636034
- Sponsor's protocol ID
- GSPB-COVID-2020
- Status last verified
- Jun 2022
- First submitted
- 18 Nov 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
- ClinicalTrials.gov ID
- NCT04636034
- Acronym / sponsor ID
- GSPB-COVID-2020
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment failure
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine-Lidocaine | Experimental | Procedure: Sphenopalatine Ganglion Block with Local Anesthetic |
| Placebo | Placebo comparator | Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl) |
| "Sham"-block with Placebo | Sham comparator | Procedure: "Sham"-block with Placebo (Isotone NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine Ganglion Block with Local AnestheticBlock performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL | Procedure or surgery | Ropivacaine-Lidocaine |
| Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)Block performed with bilaterally inserted q-tips with isotone NaCl | Procedure or surgery | Placebo |
| "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. | Procedure or surgery | "Sham"-block with Placebo |
Primary outcome
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".
Time frame: 30 minutes after block
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.
5 secondary outcomes
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
Time frame: 30 minutes and 1 week after block
Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)
Time frame: During study period until completion of 1 week follow up
Average pain intensity (0-10 on a numercial rating scale, NRS)
Time frame: During study period until completion of 1 week follow up
Number of patients needing "rescue GSP-block"
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.
Time frame: 30 minutes after block
Results and safety
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
Related trials for Headache
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Meyhoff, PhD study director
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sphenopalatine Ganglion Block with Local Anesthetic in people with Headache and Covid19, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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". (time frame: 30 minutes after block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.