Steroids in Occipital Nerve Block for Treatment of Headache

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

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.

Study Overview

• Status: Completed
• Conditions: Headache; Occipital Nerve Block
• Intervention / Treatment: Drug: Bupivacaine; Drug: Lidocaine; Drug: Normal saline; Procedure: Greater/lesser occipital nerve blocks; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anesthetic without steroid group; Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline.	Drug: Bupivacaine; 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves; Drug: Lidocaine; 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves; Drug: Normal saline; 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves; Procedure: Greater/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.
Experimental: Anesthetic with dexamethasone group; Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone.	Drug: Bupivacaine; 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves; Drug: Lidocaine; 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves; Procedure: Greater/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.; Drug: Dexamethasone; 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache days 1 week following treatment	Number of self-reported days subjects experience headaches in the past week following treatment	1 week
Headache days 2 weeks following treatment	Number of self-reported days subjects experience headaches in the past weeks following treatment	2 weeks
Headache days 4 weeks following treatment	Number of self-reported days subjects experience headaches in the past weeks following treatment	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Severity	Self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment	1 week, 2 weeks, 4 weeks
Moderate or severe headache days	Number of self-reported days subjects report headaches as being moderate or severe following treatment	1 week, 2 weeks, 4 weeks
Acute medication use	Number of self-reported days subject had to take acute pain medication for their headaches following treatment	1 week, 2 weeks, 4 weeks
Location of headache	Self-reported location of headache (front, back, other) following treatment	1 week, 2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Carrie Robertson, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Dexamethasone; Bupivacaine; Lidocaine
• Other Study ID Numbers: 22-007855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No