Sphenopalatine Ganglion Blocks RCT
Keywords
Abstract
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.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 09/07/2018 |
| Estimated Enrollment Submitted: | 09/07/2018 |
| First Posted: | 09/11/2018 |
| Last Update Submitted: | 03/23/2020 |
| Last Update Posted: | 03/25/2020 |
| Actual Study Start Date: | 01/31/2019 |
| Estimated Primary Completion Date: | 09/30/2022 |
| Estimated Study Completion Date: | 09/30/2023 |
Condition or disease
Intervention/treatment
Drug: Lidocaine
Drug: Bupivacaine
Drug: Ropivacaine
Drug: Placebo (saline)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Lidocaine Participants will receive SPG blocks with lidocaine. | Drug: Lidocaine Nasal application using the Sphenocath device- cleared by FDA |
| Experimental: Bupivacaine Participants will receive SPG blocks with bupivacaine | Drug: Bupivacaine Nasal application using the Sphenocath device- cleared by FDA |
| Experimental: Ropivacaine Participants will receive SPG blocks with ropivacaine | Drug: Ropivacaine Nasal application using the Sphenocath device- cleared by FDA |
| Placebo Comparator: Placebo (saline) Participants will receive SPG blocks with placebo (saline) | Drug: Placebo (saline) Placebo Saline using the Sphenocath device- cleared by FDA |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Reduction in headache days [8 months]
