Sphenopalatine Ganglion Blocks RCT

Study Overview
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Brief Summary
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RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

Detailed Description
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Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO. SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG. Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine. With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks. We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.

Official Title
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UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.

Conditions
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Migraine

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Bupivacaine
* Drug: Ropivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or more at time of consent Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically Ability to provide consent for the research study Exclusion Criteria Pregnant or breast feeding within 4 weeks of enrollment Inability to communicate with the study team Patients who cannot read and understand English Deemed unsuitable for enrollment in study by the investigator Allergy to local anesthetics or saline

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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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
Interventional Model Description: Randomized placebo controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Participants will receive SPG blocks with lidocaine. | Drug: Lidocaine<br>* Nasal application using the Sphenocath device- cleared by FDA<br>|
| Experimental: Bupivacaine<br>Participants will receive SPG blocks with bupivacaine | Drug: Bupivacaine<br>* Nasal application using the Sphenocath device- cleared by FDA<br>|
| Experimental: Ropivacaine<br>Participants will receive SPG blocks with ropivacaine | Drug: Ropivacaine<br>* Nasal application using the Sphenocath device- cleared by FDA<br>|
| Placebo Comparator: Placebo (saline)<br>Participants will receive SPG blocks with placebo (saline) | Drug: Placebo<br>* Placebo Saline using the Sphenocath device- cleared by FDA<br>* Other names: Placebo Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | Reduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation | 8 months |