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Sphenopalatine Ganglion Blocks RCT (SPGblock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666663
Recruitment Status : Completed
First Posted : September 12, 2018
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Migraine Drug: Lidocaine Drug: Bupivacaine Drug: Ropivacaine Drug: Placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind study
Primary Purpose: Treatment
Official Title: UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : July 8, 2021
Actual Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine
Participants will receive SPG blocks with lidocaine.
 Drug: Lidocaine
Nasal application using the Sphenocath device- cleared by FDA
Experimental: Bupivacaine
Participants will receive SPG blocks with bupivacaine
 Drug: Bupivacaine
Nasal application using the Sphenocath device- cleared by FDA
Experimental: Ropivacaine
Participants will receive SPG blocks with ropivacaine
 Drug: Ropivacaine
Nasal application using the Sphenocath device- cleared by FDA
Placebo Comparator: Placebo (saline)
Participants will receive SPG blocks with placebo (saline)
 Drug: Placebo
Placebo Saline using the Sphenocath device- cleared by FDA
Other Name: Placebo Saline


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666663


Locations
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United States, California
UCSF Headache Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Nina Riggins, MD UCSF Headache Center
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol and Statistical Analysis Plan  [PDF] November 29, 2018

More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03666663    
Other Study ID Numbers: 18-25736_SPG_2018.09
First Posted: September 12, 2018    Key Record Dates
Results First Posted: October 11, 2021
Last Update Posted: October 11, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lidocaine
Bupivacaine
Ropivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action