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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Participants will receive SPG blocks with lidocaine. |
|
| Bupivacaine | Experimental | Participants will receive SPG blocks with bupivacaine |
|
| Ropivacaine | Experimental | Participants will receive SPG blocks with ropivacaine |
|
| Placebo (saline) | Placebo Comparator | Participants will receive SPG blocks with placebo (saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Nasal application using the Sphenocath device- cleared by FDA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | 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 | 8 months |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nina Riggins, MD | UCSF Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Headache Center | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1889975 | Background | 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. | |
| 21956040 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Participants will receive SPG blocks with lidocaine. Lidocaine: Nasal application using the Sphenocath device- cleared by FDA |
| FG001 | Bupivacaine | Participants will receive SPG blocks with bupivacaine Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA |
| FG002 | Ropivacaine | Participants will receive SPG blocks with ropivacaine Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA |
| FG003 | Placebo (Saline) | Participants will receive SPG blocks with placebo (saline) Placebo: Placebo Saline using the Sphenocath device- cleared by FDA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Participants will receive SPG blocks with lidocaine. Lidocaine: Nasal application using the Sphenocath device- cleared by FDA |
| BG001 | Bupivacaine | Participants will receive SPG blocks with bupivacaine Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | 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 | Posted | Number | participants | 8 months |
|
1 year
follow up appointments and chart review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Participants will receive SPG blocks with lidocaine. Lidocaine: Nasal application using the Sphenocath device- cleared by FDA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Nina Riggins | UCSF | 7028064831 | Nina.Riggins7@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | Jul 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Randomized placebo controlled study
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Double blind study
| Bupivacaine |
| Drug |
Nasal application using the Sphenocath device- cleared by FDA |
|
| Ropivacaine | Drug | Nasal application using the Sphenocath device- cleared by FDA |
|
| Placebo | Drug | Placebo Saline using the Sphenocath device- cleared by FDA |
|
|
| 26615983 | Background | 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. |
| 30043973 | Background | 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. |
| 29862074 | Background | 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. |
| 28432602 | Background | 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. |
| BG002 | Ropivacaine | Participants will receive SPG blocks with ropivacaine Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA |
| BG003 | Placebo (Saline) | Participants will receive SPG blocks with placebo (saline) Placebo: Placebo Saline using the Sphenocath device- cleared by FDA |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 |
| Ropivacaine |
Participants will receive SPG blocks with ropivacaine Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA |
| OG003 | Placebo (Saline) | Participants will receive SPG blocks with placebo (saline) Placebo: Placebo Saline using the Sphenocath device- cleared by FDA |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Bupivacaine | Participants will receive SPG blocks with bupivacaine Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Ropivacaine | Participants will receive SPG blocks with ropivacaine Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Placebo (Saline) | Participants will receive SPG blocks with placebo (saline) Placebo: Placebo Saline using the Sphenocath device- cleared by FDA | 0 | 3 | 0 | 3 | 0 | 3 |
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| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|