Migraine
Conditions
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.
Interventions
DRUGLidocaine
Nasal application using the Sphenocath device- cleared by FDA
DRUGBupivacaine
Nasal application using the Sphenocath device- cleared by FDA
DRUGRopivacaine
Nasal application using the Sphenocath device- cleared by FDA
DRUGPlacebo
Placebo Saline using the Sphenocath device- cleared by FDA
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind study
Intervention model description
Randomized placebo controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Participants will receive SPG blocks with lidocaine.
Lidocaine: Nasal application using the Sphenocath device- cleared by FDA | 3 |
| Bupivacaine Participants will receive SPG blocks with bupivacaine
Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA | 1 |
| Ropivacaine Participants will receive SPG blocks with ropivacaine
Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA | 3 |
| Placebo (Saline) Participants will receive SPG blocks with placebo (saline)
Placebo: Placebo Saline using the Sphenocath device- cleared by FDA | 3 |
| Total | 10 |
Baseline characteristics
| Characteristic | Lidocaine | Bupivacaine | Ropivacaine | Placebo (Saline) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 1 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 | 0 / 3 | 0 / 3 |
Outcome results
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
Time frame: 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | 3 participants |
| Bupivacaine | Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | 1 participants |
| Ropivacaine | Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | 1 participants |
| Placebo (Saline) | Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment | 0 participants |