Sphenopalatine Ganglion Blocks RCT (SPG Block)
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ClinicalTrials.gov Identifier: NCT03666663 |
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Migraine | Drug: LidocaineDrug: Marcaine or RopivacaineDrug: Placebos | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Lidocaine
Lidocaine anesthetic
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Drug: Lidocaine
Lidocaine anesthetic
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Experimental: Marcaine or Ropivacaine
Marcaine or Ropivacaine or comparable anesthetic available
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Drug: Marcaine or Ropivacaine
Marcaine or Ropivacaine or comparable anesthetic available
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Placebo Comparator: Placebo (saline)
Placebo (saline)
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Drug: Placebos
Placebo Saline
Other Name: Placebo Saline
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- Reduction in headache days [ Time Frame: 16 weeks ]
Reduction in headache days from baseline to month 3 of treatment
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Current patients in the UCSF Headache Center who wish to receive SPG blocks for migraine and would otherwise receive treatment clinically
- Ability to provide consent for the research study
- Able to read and understand English
Exclusion Criteria:
- Patients who cannot read and understand English
- Deemed unsuitable for enrollment in study by the investigator
- Allergy to lidocaine, marcaine, ropivacaine, anesthetics, or saline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666663
Contact: Nina Riggins, MD | 415-885-7832 | [email protected] |
United States, California | |
UCSF Headache Center | Not yet recruiting |
San Francisco, California, United States, 94115 | |
Contact: Nina Riggins, MD 415-885-7832 [email protected] |
Principal Investigator: | Nina Riggins, MD | UCSF Headache Center |
Responsible Party: | Nina Riggins, MD, Assistant Clinical Professor of Neurology, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03666663History 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 Lidocaine Ropivacaine Bupivacaine Anesthetics |
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 |