Clinical trial NCT03666663: Sphenopalatine Ganglion Blocks RCT
Official title: UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo controlled study
Primary purpose: TREATMENT

Brief summary: RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or more at time of consent
2. Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
3. Ability to provide consent for the research study

Exclusion Criteria

1. Pregnant or breast feeding within 4 weeks of enrollment
2. Inability to communicate with the study team
3. Patients who cannot read and understand English
4. Deemed unsuitable for enrollment in study by the investigator
5. Allergy to local anesthetics or saline

Primary outcomes:
measure: Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Headache Center
state: California
Study officials:
affiliation: UCSF Headache Center
name: Nina Riggins, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.
citation: Mehta D, Leary MC, Yacoub HA, El-Hunjul M, Kincaid H, Koss V, Wachter K, Malizia D, Glassman B, Castaldo JE. The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self-Reported Pain in Patients With Status Migrainosus. Headache. 2019 Jan;59(1):69-76. doi: 10.1111/head.13390. Epub 2018 Jul 25.
citation: Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
citation: Mojica J, Mo B, Ng A. Sphenopalatine Ganglion Block in the Management of Chronic Headaches. Curr Pain Headache Rep. 2017 Jun;21(6):27. doi: 10.1007/s11916-017-0626-8.