Skip to main content
OpenTrials
Completed

NCT Number: NCT05732532

Steroids in Occipital Nerve Block for Treatment of Headache

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves

Lidocaine

Drug

0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves

Dexamethasone

Drug

0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves

normal saline

Drug

0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves

Greater/lesser occipital nerve blocks

Procedure

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.

Primary outcomes

  1. Change in Headache Days 1 Week Following Treatment

    Time frame: Baseline; 1 week

    The change in the number of self-reported days subjects experienced headaches from baseline to 1 week.

  2. Change in Headache Days 2 Weeks Following Treatment

    Time frame: Baseline; 2 weeks

    The change in the number of self-reported days subjects experienced headaches from baseline to 2 weeks

  3. Change in Headache Days 4 Weeks Following Treatment

    Time frame: Baseline; 4 weeks

    The change in the number of self-reported days subjects experienced headaches from baseline to 4 weeks.

Secondary outcomes

  1. Change in Headache Severity

    Time frame: 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.

  2. Change in Moderate or Severe Headache Days

    Time frame: 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

  3. Change in Acute Medication Use

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Treatment of Headache With Occipital Nerve Blocks: Comparison Trial of Anesthetic With or Without Dexamethasone

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.