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Steroid Occipital Nerve Block for Headache

Phase 4

Recruiting

Led By Carrie Robertson, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 2 weeks, 4 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will look at if adding a steroid to occipital nerve block improves headaches.

Who is the study for?

This trial is for individuals who can consent, have been stable on headache prevention meds for at least a month, and suffer from headaches like occipital neuralgia or migraines. It's not for pregnant people, those with allergies to the drugs used, infections at the injection site, certain head or neck issues, or recent nerve blocks.

What is being tested?

The study tests if adding dexamethasone (a steroid) to an occipital nerve block helps more than just using local anesthetics (bupivacaine and lidocaine) with saline in treating headaches. Participants will receive these treatments directly around the nerves that might cause their pain.

What are the potential side effects?

Possible side effects include reactions at the injection site such as pain or infection, allergic reactions to any of the medications used (bupivacaine, lidocaine, dexamethasone), and potential short-term increases in blood sugar levels due to steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 2 weeks, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 2 weeks, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Headache days 1 week following treatment

Headache days 2 weeks following treatment

Headache days 4 weeks following treatment

Secondary study objectives

Acute medication use

Headache Severity

Location of headache

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anesthetic with dexamethasone groupExperimental Treatment4 Interventions

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 II: Anesthetic without steroid groupActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

2013

Completed Phase 4

~1530

Lidocaine

2011

Completed Phase 4

~1370