Sphenopalatine Ganglion Block Study

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are: Does a high dose (3ml) give more relief than a low dose (1ml)? Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed. Researchers will compare dosage and administration to see how symptoms are reduced.

Official Title
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A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache

Conditions
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Sphenopalatine Ganglion Nerve Block

Intervention / Treatment
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* Drug: Bupivacaine
* Device: angiocatheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present to ED for management of headache Headache is moderate or severe in intensity Exclusion Criteria: Allergy to bupivacaine Nasal or sinus surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose with unilateral administration<br>High dose (3ml) with unilateral administration of bupivacaine | Drug: Bupivacaine<br>* Topically applied to sphenopalatine ganglion<br>Device: angiocatheter<br>* Introduced into nose to reach sphenopalatine ganglion nerve<br>|
| Active Comparator: High dose with bilateral administration<br>High dose (3ml) with bilateral administration of bupivacaine | Drug: Bupivacaine<br>* Topically applied to sphenopalatine ganglion<br>Device: angiocatheter<br>* Introduced into nose to reach sphenopalatine ganglion nerve<br>|
| Active Comparator: Low dose with unilateral administration<br>Low dose (1ml) with unilateral administration of bupivacaine | Drug: Bupivacaine<br>* Topically applied to sphenopalatine ganglion<br>Device: angiocatheter<br>* Introduced into nose to reach sphenopalatine ganglion nerve<br>|
| Active Comparator: Low dose with bilateral administration<br>Low dose (1ml) with bilateral administration of bupivacaine | Drug: Bupivacaine<br>* Topically applied to sphenopalatine ganglion<br>Device: angiocatheter<br>* Introduced into nose to reach sphenopalatine ganglion nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sphenopalatine ganglion nerve, Peripheral nerve block, Headache, Migraine