Steroids in Occipital Nerve Block for Treatment of Headache

Last updated: July 20, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

4

Condition

Pain

Pain (Pediatric)

Chronic Pain

Treatment

Greater/lesser occipital nerve blocks

Normal saline

Lidocaine

Clinical Study ID

NCT05732532
22-007855
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Treated for headache including but not limited to occipital neuralgia, episodicmigraine, chronic migraine and/or cervicogenic headache.

  • Stable on preventative medication dosing for at least 1 month prior to occipitalnerve block and no change in preventative medication regimen during the course ofthe study.

  • Able to understand the requirements of the study and return for treatment.

  • Able to independently provide informed consent.

Exclusion

Exclusion Criteria:

  • Diagnosis of cluster headache according to the International Classification ofHeadache Disorders 3rd edition.

  • Occipital or other cranial nerve block administered within 3 months prior toinitiation 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 thatprohibit use of landmark-based technique.

Study Design

Total Participants: 120
Treatment Group(s): 5
Primary Treatment: Greater/lesser occipital nerve blocks
Phase: 4
Study Start date:
February 17, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Mayo Clinic Minnesota

    Rochester, Minnesota 55905
    United States

    Site Not Available

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