VasalgiaNCT07060586
The Effect of Sphenopalatine Ganglion Block on Headache and Vasalgia
A study testing Sphenopalatine Ganglion Block in people with Vasalgia and Headache, 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 sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Sphenopalatine Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jun 2025to 21 Jun 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets screening criteria and is present on the day of intervention
- Moderate to severe headache (defined as ≥ 3 on a 0-10 VAS) on the day of intervention
Who cannot join
- Intake of alcohol or other intoxicating substances after waking up on the day of intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sphenopalatine Ganglion Block Versus Placebo on Headache the Day After Participation in Metal Festival: a Randomised Controlled Trial
The purpose of this study is to evaluate the effect of sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell.
Read the detailed description
The purpose of this study is to evaluate the effect of sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell.
Headache is one of the most commonly reported symptoms following heavy alcohol consumption and is expected to be particularly pronounced after exposure to noisy environments. Headaches can have negative consequences such as reduced cognitive function and absence from school or work despite treatment with basic pain medication.
A Danish study has previously shown that SPG block is effective against some of the most severe types of headache (e.g., post-dural puncture headache and migraine), but its potential after participation in a music festival has not yet been explored.
The mechanism and pathophysiology behind headache and veisalgia after significant alcohol intake are not well understood but are believed to be multifactorial. Headache following alcohol consumption is thought to arise from a dysreflexia that leads to cerebral vasodilation, which causes the headache. This cerebral vasodilation is mediated by the parasympathetic nervous system, partly via neurons in the sphenopalatine ganglion (SPG), which is located at the back of the nasal cavity.
Treatment that inhibits this vasodilation by blocking the SPG is still relatively new in Denmark, but a Danish study has demonstrated its effect on post-dural puncture headache, where it was found to potentially cure more than half of the cases, thus sparing patients further invasive treatment. However, the study concluded that much of the block's effect could not necessarily be attributed to the local anesthetic but might instead be due to mechanical stimulation of the ganglion.
In addition to its effect on post-dural puncture headache, the block has also been shown to be effective in migraine, where a similar mechanism is assumed.
The treatment with transnasal sphenopalatine ganglion block (SPG block) is simple and minimally invasive, performed by gently inserting a cotton swab with local anesthetic through the patient's nostril to the back wall of the nasal cavity where the ganglion is located. The block has few reported side effects and can be performed with minimal resources.
- Being tested
- Sphenopalatine Ganglion Block, Sham Block
- Keywords
- Hangover, SPGB
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockProcedure or surgery
A bilateral transnasal sphenopalatine ganglion block with cotton tips soaked in a mixture of 0.5 mL lidocaine 4% and 0.5 mL ropivacaine 0.5% plus injection through the cotton tips of an additional 1 mL of the mixture. The Danish Medicines Agency waived need for approval as this procedure is not considered a pharmaceutical intervention.
Sham BlockProcedure or surgery
A sham block with two bilaterally inserted cotton tips not reaching the posterior part of the nasopharyngeal making not contact with the ganglion. Cotton tips are soaked in 1 mL placebo (saline) and have a total of 1 mL saline injected through the cotton tips. The Danish Medicines Agency waived need for approval as this procedure is not considered a pharmaceutical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Block (Lidocaine + Ropivacaine) | Experimental | Not described Receives: Procedure: Sphenopalatine Ganglion Block |
| Sham block (Saline) | Sham comparator | Incomplete block with saline (no contact with ganglion) Receives: Procedure: Sham Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain Intensity 10 minutes after SPGB
Pain intensity (0-100 mm on a visual analog scale, VAS) of the headache in a standing position 10 minutes after administration of the block in the Ropivacaine-Lidocaine group and the Sham group.
Pain intensity is measured as the worst pain experienced after the person has been standing for 30 seconds, or as the worst pain during the attempt to stand if the test must be aborted.
Measured: 10 minutes following block
Secondary outcomes (4)
Pain score below 30mm (VAS)
Frequency of individuals with a pain score below 30 mm in a standing position (on a visual analog scale, VAS, 0-100 mm ) at 10 minutes after block administration.
Measured: 10 minutes following block
Difference in headache pain intensity in standing position
Difference in pain intensity (0-100 mm on a visual analog scale, VAS) of the headache in the standing position 10 minutes after administration of the block in the Ropivacaine-Lidocaine group and the Sham group. Pain intensity is measured as the worst pain experienced after the person has been standing for 30 seconds, or as the worst pain during the attempt to stand if the test must be aborted. The difference is calculated as the pain intensity after the block minus the pain intensity at baseline before the block.
Measured: 10 minutes following block
Severity of veisalgia
The severity of veisalgia (assessed using the Alcohol Hangover Severity Scale (AHSS)) 10 minutes after block administration. Range of AHSS, 0-120, higher scores worst.
Measured: 10 minutes following block
Difference in veisalgia severity
Difference in vasalgia (assessed using the Alcohol Hangover Severity Scale (AHSS)) 10 minutes after block administration. Range of AHSS, 0-120, higher scores worst.
Measured: 10 minutes following block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start18 Jun 2025
- Primary completion21 Jun 2025
- Study completion21 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasalgiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian S. Meyhoff, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060586
- Sponsor's protocol ID
- SPGCPHHell
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only if data sharing is accepted by Data Mangement Agency upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sphenopalatine Ganglion Block Versus Placebo on Headache the Day After Participation in Metal Festival: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07060586
- Acronym / sponsor ID
- SPGCPHHell
- Keywords
- Hangover, SPGB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 21 Jun 2025 (actual)
- First posted
- 11 Jul 2025 (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 sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell.
Detailed description
The purpose of this study is to evaluate the effect of sphenopalatine ganglion block (SPG block) on headache and veisalgia (hangover) the day after attending the metal festival Copenhell.
Headache is one of the most commonly reported symptoms following heavy alcohol consumption and is expected to be particularly pronounced after exposure to noisy environments. Headaches can have negative consequences such as reduced cognitive function and absence from school or work despite treatment with basic pain medication.
A Danish study has previously shown that SPG block is effective against some of the most severe types of headache (e.g., post-dural puncture headache and migraine), but its potential after participation in a music festival has not yet been explored.
The mechanism and pathophysiology behind headache and veisalgia after significant alcohol intake are not well understood but are believed to be multifactorial. Headache following alcohol consumption is thought to arise from a dysreflexia that leads to cerebral vasodilation, which causes the headache. This cerebral vasodilation is mediated by the parasympathetic nervous system, partly via neurons in the sphenopalatine ganglion (SPG), which is located at the back of the nasal cavity.
Treatment that inhibits this vasodilation by blocking the SPG is still relatively new in Denmark, but a Danish study has demonstrated its effect on post-dural puncture headache, where it was found to potentially cure more than half of the cases, thus sparing patients further invasive treatment. However, the study concluded that much of the block's effect could not necessarily be attributed to the local anesthetic but might instead be due to mechanical stimulation of the ganglion.
In addition to its effect on post-dural puncture headache, the block has also been shown to be effective in migraine, where a similar mechanism is assumed.
The treatment with transnasal sphenopalatine ganglion block (SPG block) is simple and minimally invasive, performed by gently inserting a cotton swab with local anesthetic through the patient's nostril to the back wall of the nasal cavity where the ganglion is located. The block has few reported side effects and can be performed with minimal resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block (Lidocaine + Ropivacaine) | Experimental | Procedure: Sphenopalatine Ganglion Block |
| Sham block (Saline) | Sham comparator | Procedure: Sham BlockIncomplete block with saline (no contact with ganglion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets screening criteria and is present on the day of intervention
- Moderate to severe headache (defined as ≥ 3 on a 0-10 VAS) on the day of intervention
Key exclusion criteria (1 listed)
- Intake of alcohol or other intoxicating substances after waking up on the day of intervention.
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 BlockA bilateral transnasal sphenopalatine ganglion block with cotton tips soaked in a mixture of 0.5 mL lidocaine 4% and 0.5 mL ropivacaine 0.5% plus injection through the cotton tips of an additional 1 mL of the mixture. The Danish Medicines Agency waived need for approval as this procedure is not considered a pharmaceutical intervention. | Procedure or surgery | Block (Lidocaine + Ropivacaine) |
| Sham BlockA sham block with two bilaterally inserted cotton tips not reaching the posterior part of the nasopharyngeal making not contact with the ganglion. Cotton tips are soaked in 1 mL placebo (saline) and have a total of 1 mL saline injected through the cotton tips. The Danish Medicines Agency waived need for approval as this procedure is not considered a pharmaceutical intervention. | Procedure or surgery | Sham block (Saline) |
Primary outcome
Headache Pain Intensity 10 minutes after SPGB
Time frame: 10 minutes following block
Pain intensity (0-100 mm on a visual analog scale, VAS) of the headache in a standing position 10 minutes after administration of the block in the Ropivacaine-Lidocaine group and the Sham group. Pain intensity is measured as the worst pain experienced after the person has been standing for 30 seconds, or as the worst pain during the attempt to stand if the test must be aborted.
4 secondary outcomes
Pain score below 30mm (VAS)
Time frame: 10 minutes following block
Difference in headache pain intensity in standing position
Time frame: 10 minutes following block
Severity of veisalgia
Time frame: 10 minutes following block
Difference in veisalgia severity
Time frame: 10 minutes following block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided. Only if data sharing is accepted by Data Mangement Agency upon request.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine Ganglion Block in people with Vasalgia and Headache, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jul 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Headache Pain Intensity 10 minutes after SPGB (time frame: 10 minutes following 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 11 Jul 2025.