Steroids in Occipital Nerve Block for Treatment of Headache

NCT05732532 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 22-007855
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Occipital Nerve Block

Outcome Measures

Primary Outcomes (3)

• Change in Headache Days 1 Week Following Treatment

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

  Baseline; 1 week

• Change in Headache Days 2 Weeks Following Treatment

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

  Baseline; 2 weeks

• Change in Headache Days 4 Weeks Following Treatment

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

  Baseline; 4 weeks

Secondary Outcomes (3)

• Change in Headache Severity

  Baseline,1 week, 2 weeks, 4 weeks

• Change in Moderate or Severe Headache Days

  Baseline, 1 week, 2 weeks, 4 weeks

• Change in Acute Medication Use

  Baseline, 1 week, 2 weeks, 4 weeks

Study Arms (2)

Anesthetic without steroid group

ACTIVE COMPARATOR

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; Drug: Lidocaine; Drug: Normal saline; Procedure: Greater/lesser occipital nerve blocks

Anesthetic with dexamethasone group

EXPERIMENTAL

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; Drug: Lidocaine; Drug: Dexamethasone; Procedure: Greater/lesser occipital nerve blocks

Interventions

Bupivacaine DRUG

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

Anesthetic with dexamethasone group; Anesthetic without steroid group

Normal saline DRUG

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

Anesthetic without steroid group

Lidocaine DRUG

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

Anesthetic with dexamethasone group; Anesthetic without steroid group

Dexamethasone DRUG

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

Anesthetic with dexamethasone group

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.

Anesthetic with dexamethasone group; Anesthetic without steroid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Bupivacaine; Lidocaine; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Carrie (Beth) Robertson, M.D.
• Organization: Mayo Clinic

robertson.carrie@mayo.edu

507-266-4106

Study Officials

• Carrie Robertson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 17, 2023
• Study Start: February 17, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 24, 2026
• Results First Posted: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)