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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

September 8, 2018
September 12, 2018
December 4, 2018
February 1, 2019
October 1, 2022   (Final data collection date for primary outcome measure)
Reduction in headache days [ Time Frame: 8 months ]
Reduction in headache days from baseline to month 8 of treatment
Reduction in headache days [ Time Frame: 16 weeks ]
Reduction in headache days from baseline to month 3 of treatment
Complete list of historical versions of study NCT03666663 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sphenopalatine Ganglion Blocks RCT
UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

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.

Interventional
Phase 4
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
Migraine
  • Drug: Lidocaine
    Nasal application using the Sphenocath device- cleared by FDA
  • Drug: Bupivacaine
    Nasal application using the Sphenocath device- cleared by FDA
  • Drug: Ropivacaine
    Nasal application using the Sphenocath device- cleared by FDA
  • Drug: Placebo
    Placebo Saline using the Sphenocath device- cleared by FDA
    Other Name: Placebo Saline
  • Experimental: Lidocaine
    Participants will receive SPG blocks with lidocaine.
    Intervention: Drug: Lidocaine
  • Experimental: Bupivacaine
    Participants will receive SPG blocks with bupivacaine
    Intervention: Drug: Bupivacaine
  • Experimental: Ropivacaine
    Participants will receive SPG blocks with ropivacaine
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: Placebo (saline)
    Participants will receive SPG blocks with placebo (saline)
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
100
October 1, 2023
October 1, 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Nina Riggins, MD 415-353-8393 nina.riggins@ucsf.edu
United States
 
 
NCT03666663
18-25736_SPG_2018.09
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
Plan to Share IPD: No
Nina Riggins, MD, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Nina Riggins, MD UCSF Headache Center
University of California, San Francisco
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP