Sphenopalatine Ganglion Blocks RCT

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: Ropivacaine; Drug: Placebo; Drug: Bupivacaine; Drug: Lidocaine

• Registration Number: NCT03666663
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-08
• Study First Posted: 2018-09-12
• Study Start: 2019-02-01
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Results First Submitted: 2021-07-21
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Results First Posted: 2021-10-11
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine	Participants will receive SPG blocks with ropivacaine
Placebo (saline)	Placebo	Participants will receive SPG blocks with placebo (saline)
Bupivacaine	Bupivacaine	Participants will receive SPG blocks with bupivacaine
Lidocaine	Lidocaine	Participants will receive SPG blocks with lidocaine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment	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

Trial Locations

Locations (1)

UCSF Headache Center; 🇺🇸 San Francisco, California, United States