Sphenopalatine Nerve Block for Headache Tx360

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.

Official Title
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A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management

Conditions
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Headache, Migraine

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are 18 - 65 years of age present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region) have a normal neurological exams Exclusion Criteria: are less than 18 years old or greater than 65 have any focal neurological dysfunction signs or symptoms have a posterior/occipital/cervicogenic source predominance of headache are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches have self treated with pain medication or anti-emetic 4 hours prior to arrival have a history of peripheral vascular disease, cancer, or HIV infection are known to be pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>Bupivicaine .03ml to each nare | Drug: Bupivacaine<br>* Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion<br>|
| Placebo Comparator: Normal Saline<br>normal saline .03 ml to each nare | Drug: Placebo<br>* Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale |  | 15 minutes from dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical Pain Relief | Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided. | 15 minutes from dose | 
| Headache Free at 24 Hours | The percentage of patients that were headache free at 24 hours by follow-up phone conversation. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Migraine