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Sphenopalatine Ganglion Blocks RCT (SPGblock)

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ClinicalTrials.gov Identifier: NCT03666663
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Nina Riggins, MD, University of California, San Francisco

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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.
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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




Primary Outcome Measures :
  1. Reduction in headache days [ Time Frame: 8 months ]
    Reduction in headache days from baseline to month 8 of treatment



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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

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


Contacts
Contact: Nina Riggins, MD 415-353-8393 nina.riggins@ucsf.edu

Locations
United States, California
UCSF Headache Center Not yet recruiting
San Francisco, California, United States, 94115
Contact: Nina Riggins, MD    415-353-8393    nina.riggins@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Nina Riggins, MD UCSF Headache Center

Publications of Results:

Responsible Party: Nina Riggins, MD, Assistant Clinical Professor of Neurology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03666663     History of Changes
Other Study ID Numbers: 18-25736_SPG_2018.09
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
Lidocaine
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