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Completed

NCT Number: NCT03666663

Sphenopalatine Ganglion Blocks RCT

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSF Headache Center

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Nasal application using the Sphenocath device- cleared by FDA

Bupivacaine

Drug

Nasal application using the Sphenocath device- cleared by FDA

Ropivacaine

Drug

Nasal application using the Sphenocath device- cleared by FDA

Placebo

Drug

Placebo Saline using the Sphenocath device- cleared by FDA

Other names: Placebo Saline

Primary outcomes

  1. Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment

    Time frame: 8 months

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: SPGblock

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2018
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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