Clinical trial NCT05732532: Steroids in Occipital Nerve Block for Treatment of Headache
Official title: Treatment of Headache With Occipital Nerve Blocks: Comparison Trial of Anesthetic With or Without Dexamethasone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Headache
Occipital Nerve Block
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache days 1 week following treatment
timeFrame: 1 week
measure: Headache days 2 weeks following treatment
timeFrame: 2 weeks
measure: Headache days 4 weeks following treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Headache Severity
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Moderate or severe headache days
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Acute medication use
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Location of headache
timeFrame: 1 week, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carrie Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References: