Sphenopalatine Ganglion Block Study | NCT05707754 | Trialant

Sphenopalatine Ganglion Block Study | NCT05707754 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High dose with unilateral administration	Active Comparator	High dose (3ml) with unilateral administration of bupivacaine	Drug: Bupivacaine Device: angiocatheter
High dose with bilateral administration	Active Comparator	High dose (3ml) with bilateral administration of bupivacaine	Drug: Bupivacaine Device: angiocatheter
Low dose with unilateral administration	Active Comparator	Low dose (1ml) with unilateral administration of bupivacaine	Drug: Bupivacaine Device: angiocatheter
Low dose with bilateral administration	Active Comparator	Low dose (1ml) with bilateral administration of bupivacaine	Drug: Bupivacaine Device: angiocatheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug	Topically applied to sphenopalatine ganglion	High dose with bilateral administration High dose with unilateral administration Low dose with bilateral administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants demonstrating sustained headache relief	A standard ordinal headache intensity scale will be used for participants to describe their headache as either "severe", "moderate", "mild", or "none". The number of participants who are able to achieve a headache level of "mild" or "none" in the ED within 30 minutes of procedure/medication administration and without requiring additional analgesic medication, and not relapsing to a headache level worse than "mild" during the 48 hours after medication administration, will be determined	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of participants demonstrating satisfaction with the procedure/medication	Satisfaction with the procedure/medication as evidenced by the number of participants who provide an affirmative response to the question "Do you want to receive the same procedure/medication the next time you come to the ER with migraine?"	48 hours

Other Outcomes

Measure	Description	Time Frame
Number of participants demonstrating improvement in 0-10 pain scale	Pain will be assessed using an 11-point numerical rating scale (NRS) as recommended for use in migraine research by the International Headache Society. The NRS scale asks subjects to assign their pain a number between 0 and 10, with 0 = no pain and 10 = worst pain imaginable. Pain scores will be ascertained prior to procedure and at one hour

Contacts/Locations Module

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