Sphenopalatine Ganglion Blocks RCT (SPGblock)

• 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: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: September 8, 2018
• First Posted Date: September 12, 2018
• Results First Submitted Date: July 21, 2021
• Results First Posted Date: October 11, 2021
• Last Update Posted Date: October 11, 2021
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: July 8, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2021)

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

Original Primary Outcome Measures (submitted: September 8, 2018)

Reduction in headache days [ Time Frame: 16 weeks ]

Reduction in headache days from baseline to month 3 of treatment

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sphenopalatine Ganglion Blocks RCT
• Official Title: UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
• Brief Summary: RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

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
• Study Phase: Phase 4

Study Design

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

• Condition: Migraine

Intervention

• 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

Study Arms

• 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

Publications *

• Goadsby PJ, Zagami AS, Lambert GA. Neural processing of craniovascular pain: a synthesis of the central structures involved in migraine. Headache. 1991 Jun;31(6):365-71. doi: 10.1111/j.1526-4610.1991.hed3106365.x.
• Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29. Erratum In: Pain Pract. 2012 Nov;12(8):673.
• Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.
• Mehta D, Leary MC, Yacoub HA, El-Hunjul M, Kincaid H, Koss V, Wachter K, Malizia D, Glassman B, Castaldo JE. The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self-Reported Pain in Patients With Status Migrainosus. Headache. 2019 Jan;59(1):69-76. doi: 10.1111/head.13390. Epub 2018 Jul 25.
• Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
• Mojica J, Mo B, Ng A. Sphenopalatine Ganglion Block in the Management of Chronic Headaches. Curr Pain Headache Rep. 2017 Jun;21(6):27. doi: 10.1007/s11916-017-0626-8. Erratum In: Curr Pain Headache Rep. 2017 Nov 20;21(12 ):53. Mojica, Jeffery [corrected to Mojica, Jeffrey].

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 30, 2021): 10
• Original Estimated Enrollment (submitted: September 8, 2018): 100
• Actual Study Completion Date: July 8, 2021
• Actual Primary Completion Date: July 8, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03666663
• Other Study ID Numbers: 18-25736_SPG_2018.09
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Nina Riggins, MD, University of California, San Francisco, Assistant Clinical Professor of Neurology
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nina Riggins, MD; UCSF Headache Center

• PRS Account: University of California, San Francisco
• Verification Date: September 2021