The Effect of Sphenopalatine Ganglion Block on Headache and Vasalgia

NCT07060586 | Completed DMC

• 1 other identifier: SPGCPHHell
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasalgia; Headache; Hangover

Keywords

Hangover; SPGB

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes following block

Secondary Outcomes (4)

• Pain score below 30mm (VAS)

  10 minutes following block

• Difference in headache pain intensity in standing position

  10 minutes following block

• Severity of veisalgia

  10 minutes following block

• Difference in veisalgia severity

  10 minutes following block

Study Arms (2)

Block (Lidocaine + Ropivacaine)

EXPERIMENTAL

Procedure: Sphenopalatine Ganglion Block

Sham block (Saline)

SHAM COMPARATOR

Incomplete block with saline (no contact with ganglion)

Procedure: Sham Block

Interventions

Sphenopalatine Ganglion Block PROCEDURE

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.

Block (Lidocaine + Ropivacaine)

Sham Block PROCEDURE

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.

Sham block (Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intake of alcohol or other intoxicating substances after waking up on the day of intervention.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Copenhell 2025

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Headache

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: June 18, 2025
• Primary Completion: June 21, 2025
• Study Completion: June 21, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

DK (1)