Steroids in Occipital Nerve Block for Treatment of Headache

NCT ID: NCT05732532

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2025-06-01

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.

Conditions

Headache; Occipital Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Normal saline

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Greater/lesser occipital nerve blocks

Intervention Type: 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.

Interventions

Bupivacaine

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

Intervention Type: DRUG

Lidocaine

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Carrie (Beth) E. Robertson, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carrie Robertson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

22-007855

Identifier Type: -

Identifier Source: org_study_id