Headache, Occipital Nerve Block
Conditions
Brief summary
Currently there is limited evidence of benefit for the addition of steroids to occipital nerve blocks for treatment of headache, and not all steroids have been explored. The purpose of this research is to learn more about whether the addition of a specific kind of steroid (dexamethasone) provides any additional benefit to nerve blocks.
Detailed description
Patients who are referred by their neurology provider for occipital nerve block as treatment of headache according to current accepted standard of care will be considered for this study. Baseline data will be obtained from the patients prior to proceeding with their nerve block and their headache diagnosis will be recorded based on electronic medical record review. Patients will be randomized to one of two treatment arms, anesthetic with dexamethasone or anesthetic without dexamethasone. The injectate will be the same color and amount of solution for each trial arm. Thus, the neurology provider performing the injection remains blinded and the patient remains blinded. Injection sites will be inspected to ensure no active bleeding, infection, cranial bone or cervical spine defects/prior surgeries that prohibit safe use of landmark-based technique. A neurologist who is experienced at performing nerve blocks will administer the injections to the bilateral greater and lesser occipital nerves using the landmark-based technique. The occipital protuberance and mastoid process are palpated, with the location of the greater occipital nerve at approximately 1/3 the distance laterally and the lesser occipital nerve at approximately 2/3 the distance laterally along the nuchal ridge for a total of 4 injection sites. Patients will be observed for approximately 10 minutes after the procedure to monitor for any immediate adverse effects and to ensure that anesthesia in the distribution of the injected nerves was achieved. Then, they will be instructed to keep a headache diary after treatment and will be provided a written example diary. A study staff who remains blinded to the patient's trial arm (but not necessarily the neurology provider who performed the injection) will contact the patients via telephone at 1, 2 and 4 weeks to assess response to treatment.
Interventions
DRUGBupivacaine
2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
DRUGLidocaine
0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
DRUGDexamethasone
0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
DRUGNormal saline
0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
PROCEDUREGreater/lesser occipital nerve blocks
Subjects will receive a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treated for headache including but not limited to occipital neuralgia, episodic migraine, chronic migraine and/or cervicogenic headache. * Stable on preventative medication dosing for at least 1 month prior to occipital nerve block and no change in preventative medication regimen during the course of the study. * Able to understand the requirements of the study and return for treatment. * Able to independently provide informed consent.
Exclusion criteria
* Diagnosis of cluster headache according to the International Classification of Headache Disorders 3rd edition. * Occipital or other cranial nerve block administered within 3 months prior to initiation of study. * History of adverse reaction or contraindication to any of the study ingredients (bupivacaine, lidocaine, dexamethasone). * Pregnancy. * Infection or bleeding at site of injection. * Cranial bone or cervical spine defects/prior surgeries near injection site that prohibit use of landmark-based technique.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Days 1 Week Following Treatment | Baseline; 1 week | The change in the number of self-reported days subjects experienced headaches from baseline to 1 week. |
| Change in Headache Days 2 Weeks Following Treatment | Baseline; 2 weeks | The change in the number of self-reported days subjects experienced headaches from baseline to 2 weeks |
| Change in Headache Days 4 Weeks Following Treatment | Baseline; 4 weeks | The change in the number of self-reported days subjects experienced headaches from baseline to 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Severity | Baseline,1 week, 2 weeks, 4 weeks | The change in the self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment with higher scores indicating worse pain. |
| Change in Moderate or Severe Headache Days | Baseline, 1 week, 2 weeks, 4 weeks | The change in the number of self-reported days subjects reported headaches as being moderate or severe following treatment |
| Change in Acute Medication Use | Baseline, 1 week, 2 weeks, 4 weeks | The change in the number of self-reported days subjects had to take acute pain medication for their headaches following treatment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarrie Robertson, MD
Mayo Clinic
Participant flow
Pre-assignment details
Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, or data anlaysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 13.9 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 60 |
| other Total, other adverse events | 4 / 58 | 6 / 60 |
| serious Total, serious adverse events | 0 / 58 | 0 / 60 |
Outcome results
None listed