Sphenopalatine Ganglion Blocks RCT (SPG Block)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03666663
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
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: Marcaine or Ropivacaine Drug: Placebos Phase 2

Detailed Description:

Migraine is a disabling brain disorder with high prevalence. SPG blocks are widely used as an acute treatment of migraine; although the preventive effects have not been widely studied.

The sphenopalatine ganglion is located in the pterygopalatine ganglia close to the sphenopalatine foramen and is located below the maxillary nerve as it crosses the fossa. The sphenopalatine ganglion has multiple connections to facial, trigeminal, parasympathetic and sympathetic systems.

Due to the unique location it is possible to interrupt a pain signal by administering SPG blocks. As with many other preventive treatments, it appears to take up to 3-4 months to see long term headache benefit.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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: Prevention
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 : October 1, 2018
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
Drug Information available for: Lidocaine

Arm Intervention/treatment
Experimental: Lidocaine
Lidocaine anesthetic
Drug: Lidocaine
Lidocaine anesthetic

Experimental: Marcaine or Ropivacaine
Marcaine or Ropivacaine or comparable anesthetic available
Drug: Marcaine or Ropivacaine
Marcaine or Ropivacaine or comparable anesthetic available

Placebo Comparator: Placebo (saline)
Placebo (saline)
Drug: Placebos
Placebo Saline
Other Name: Placebo Saline

Primary Outcome Measures :
  1. Reduction in headache days [ Time Frame: 16 weeks ]
    Reduction in headache days from baseline to month 3 of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Current patients in the UCSF Headache Center who wish to receive SPG blocks for migraine and would otherwise receive treatment clinically
  2. Ability to provide consent for the research study
  3. Able to read and understand English

Exclusion Criteria:

  1. Patients who cannot read and understand English
  2. Deemed unsuitable for enrollment in study by the investigator
  3. Allergy to lidocaine, marcaine, ropivacaine, 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 identifier (NCT number): NCT03666663

Contact: Nina Riggins, MD 415-885-7832

United States, California
UCSF Headache Center Not yet recruiting
San Francisco, California, United States, 94115
Contact: Nina Riggins, MD    415-885-7832   
Sponsors and Collaborators
University of California, San Francisco
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 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: September 12, 2018
Last Verified: September 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
Anesthetics, Local
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