The Effect of Sphenopalatine Ganglion Block on Headache and Vasalgia
NCT ID: NCT07060586
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2025-06-18
2025-06-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Block (Lidocaine + Ropivacaine)
Sphenopalatine Ganglion Block
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 block (Saline)
Incomplete block with saline (no contact with ganglion)
Sham Block
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.
Interventions
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Sphenopalatine Ganglion Block
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 Block
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.
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe headache (defined as ≥ 3 on a 0-10 VAS) on the day of intervention
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
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Christian S. Meyhoff
MD, PhD, Professor
Locations
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Copenhell 2025
Copenhagen, , Denmark
Countries
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Other Identifiers
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SPGCPHHell
Identifier Type: -
Identifier Source: org_study_id
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