An interventional study of Sphenopalatine Ganglion Block and Sham Block in Vasalgia, Headache and Hangover, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Not applicable, Interventional, and Treatment
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.
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.
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 918 interventional studies indexed under Headache.
Browse Headache studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
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Screening Criteria:
Inclusion Criteria:
Exclusion Criteria:
Procedure: Sphenopalatine Ganglion Block
Incomplete block with saline (no contact with ganglion)
Procedure: Sham 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.
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.
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.
Time frame: 10 minutes following block
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 minutes following block
Plan to share: Undecided — Only if data sharing is accepted by Data Mangement Agency upon request.
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University Hospital Bispebjerg and Frederiksberg