Steroid Occipital Nerve Block for Headache

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Cluster headache, Pregnancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a steroid called dexamethasone to occipital nerve blocks can better relieve headaches. Researchers aim to determine if this combination offers more benefits than nerve blocks alone. Participants will receive either the standard anesthetic treatment or the anesthetic plus dexamethasone. The trial seeks individuals who have been treated for headaches such as migraines or occipital neuralgia, with stable medication for at least a month. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stay on your current preventative medication without any changes during the study.

What is the safety track record for these treatments?

Research has shown that occipital nerve blocks, which involve injecting medicine near the nerves at the back of the head, are generally safe and well-tolerated. Studies have found that this procedure can effectively treat different types of headaches, such as migraines and cluster headaches, without serious safety concerns.

The steroid dexamethasone, currently under study for its potential additional benefits in these nerve blocks, is already FDA-approved for other uses. This approval indicates that dexamethasone is generally safe for humans when used correctly. However, researchers are still examining the specific effects of adding it to occipital nerve blocks. So far, the available evidence has not shown any major safety issues. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using dexamethasone in occipital nerve blocks for headaches because it offers a potential enhancement to the standard treatment. Unlike the usual anesthetics like lidocaine and bupivacaine that simply numb the area, adding dexamethasone, a powerful steroid, could provide longer-lasting pain relief by reducing inflammation around the nerves. This means patients might experience extended periods without headaches compared to the more short-lived effects of anesthetics alone.

What evidence suggests that the addition of dexamethasone to occipital nerve blocks could be effective for headaches?

Research has shown that greater occipital nerve blocks can reduce headache intensity and frequency. One study found that patients experienced fewer headaches during the first two months after receiving treatment with local pain-numbing medicine. Notably, 95% of patients who tried the occipital nerve block reported good results lasting at least six months. In this trial, one group will receive the standard occipital nerve block without steroids, while another group will receive the nerve block with dexamethasone. The main focus is to determine if adding dexamethasone enhances the treatment's effectiveness, although evidence on its additional benefits remains limited. ^{2 3 6 7 8}

Who Is on the Research Team?

Carrie Robertson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to independently provide informed consent.

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.

Exclusion Criteria

Pregnancy.

You have had a bad reaction to bupivacaine, lidocaine, or dexamethasone in the past.

You have an infection or bleeding where the injection will be given.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive occipital nerve blocks with or without dexamethasone

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Greater/Lesser Occipital Nerve Blocks

Trial Overview

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.

How Is the Trial Designed?

Group I: Anesthetic with dexamethasone group Experimental Treatment 4 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 group Active Control 4 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

This case report describes a patient with chronic migraines who successfully received occipital nerve blocks (ONBs) using only corticosteroids, highlighting a potential alternative for patients allergic to local anesthetics.

This is the first published case demonstrating the efficacy of ONBs with corticosteroids alone, suggesting that corticosteroids may be effective in managing migraines without the need for local anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of migraine with occipital nerve blocks using only corticosteroids. Tobin, J., Flitman, S.[2013]

A new ultrasound-guided injection site for the greater occipital nerve (GON) at the C2 level showed a 100% success rate in dye visualization, compared to an 80% success rate at the classical site near the superior nuchal line, based on a study involving 20 injections in cadavers.

The new approach not only improved the accuracy of the nerve blockade but also allows for a more precise targeting of the GON, which could enhance treatment outcomes for headache management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonographic visualization and ultrasound-guided blockade of the greater occipital nerve: a comparison of two selective techniques confirmed by anatomical dissection. Greher, M., Moriggl, B., Curatolo, M., et al.[2022]

A male patient experienced headaches associated with sexual activity, which were effectively treated with an injection of a steroid and local anesthetic into the greater occipital nerve.

The procedure resulted in the immediate cessation of the orgasmic headache, suggesting that this nerve block may be a viable treatment option for similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orgasmic headache responsive to greater occipital nerve blockade. Selekler, M., Kutlu, A., Dundar, G.[2013]

Occipital nerve block (ONB) with a combination of local anesthetic and corticosteroid did not show a significant reduction in the frequency of moderate to severe migraine days compared to a placebo, with both groups having a 30% response rate.

The study involved 69 patients with episodic or chronic migraines, and the results suggest that ONB may not be an effective preventive treatment for migraines, as there was no substantial difference in outcomes between the active and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. Dilli, E., Halker, R., Vargas, B., et al.[2017]

Occipital nerve blocks, while generally considered safe for treating headache syndromes, can lead to rare complications such as temporary facial nerve palsy, as demonstrated in a case involving a 24-year-old woman.

The facial nerve palsy occurred shortly after the nerve block, likely due to unintended spread of the anesthetic or anatomical variations, highlighting the need for clinicians to be aware of this potential risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient facial nerve palsy after occipital nerve block: a case report. Strauss, L., Loder, E., Rizzoli, P.[2014]

In a review of 43 patients with cluster headaches, oral steroids were found to be more effective than greater occipital nerve (GON) injections, with 82.7% of oral steroid encounters resulting in at least a partial response compared to 64.4% for GON injections.

The study suggests that both treatments are beneficial for transitional therapy in cluster headaches, but highlights that oral steroids led to a higher rate of complete responses (50.6% vs 35.6% for GON injections).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater Occipital Nerve Injection versus Oral Steroids for Short Term Prophylaxis of Cluster Headache: A Retrospective Comparative Study. Wei, J., Robbins, MS.[2019]

In a study of 190 patients with migraines, occipital nerve block demonstrated significant efficacy, with 27% of patients reporting immediate relief and 42% experiencing a reduction in pain scores to 0-2 after treatment.

The procedure was found to be safe, with only 3% of patients reporting adverse reactions, indicating that occipital nerve block can be a reliable adjunctive therapy for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines. Ebied, AM., Nguyen, DT., Dang, T.[2021]

Occipital nerve block is generally considered a safe and effective treatment for occipital neuralgia and other headache types, but there is a risk of complications, as demonstrated by a case of epidural abscess occurring 16 days post-procedure.

This case highlights the critical need for strict aseptic techniques during the procedure to minimize infection risks, reminding clinicians to be vigilant about potential complications even in otherwise healthy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital osteomylelitis and epidural abscess after occipital nerve block: A case report. Christie, SD., Kureshi, N., Beauprie, I., et al.[2022]

A patient receiving occipital nerve block injections for chronic daily headaches developed Cushing syndrome, indicating that the corticosteroid component of these injections can lead to significant side effects.

This case highlights the need for caution when using synthetic corticosteroids in nerve block procedures, especially with long-acting formulations, as they can cause serious complications like Cushing syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cushing syndrome induced by serial occipital nerve blocks containing corticosteroids. Lavin, PJ., Workman, R.[2013]

Greater occipital nerve block (GONB) significantly reduces pain scores in patients suffering from postdural puncture headache (PDPH) at 1, 6, and 24 hours post-procedure, with a mean difference of -2.66 at 24 hours based on a review of 7 studies involving 275 patients.

GONB also lowers the risk of intervention failure by 60%, indicating it is an effective therapeutic option for managing PDPH in both obstetric and nonobstetric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of greater occipital nerve block for pain relief in patients with postdural puncture headache: A meta-analysis. Chang, YJ., Hung, KC., Chen, IW., et al.[2023]

Occipital nerve blocks have been used for over 50 years in headache treatment, showing benefits for conditions like migraine, cluster headache, and postconcussive headache, primarily through case series studies.

Controlled trials indicate that combining injectable steroids with local anesthetics in occipital nerve blocks can effectively relieve cluster headache symptoms, and similar positive results were observed in trials for occipital neuralgia, which may overlap with chronic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blocking the greater occipital nerve: utility in headache management. Young, WB.[2021]

The study established specific anatomical measurements for the greater occipital nerve (GON), which can aid in more accurate GON block procedures, with distances measured from the external occipital protuberance to the GON being approximately 23.1 mm on the right and 20.5 mm on the left.

Patients receiving ultrasound-guided GON blocks experienced significantly greater pain relief compared to those receiving conventional blind blocks, with a reduction in VAS scores from 6.4 to 2.3 in the ultrasound group versus 6.5 to 3.8 in the blind group after 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided greater occipital nerve block for patients with occipital headache and short term follow up. Shim, JH., Ko, SY., Bang, MR., et al.[2021]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/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 ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2387020623002905

Greater occipital nerve block in the treatment of headaches ...

Greater occipital block is an effective and safe technique, easy to perform and which has shown its usefulness in migraine, cluster headache, cervicogenic ...

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bmcneurol.biomedcentral.com

bmcneurol.biomedcentral.com/articles/10.1186/s12883-024-03834-6

Assessing the effectiveness of greater occipital nerve block in ...

A remarkable reduction in headache intensity and frequency during the first and second months of treatment with GONB using local anesthetics ...

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tjn.org.tr

tjn.org.tr/full-text/2164/eng

The comparative clinical effectiveness of withdrawal ...

The results showed significant improvements in all three treatment groups. Group A (withdrawal protocol) demonstrated a 53% reduction in headache frequency, ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6130929/

Effectiveness of treatment of occipital neuralgia using the ...

Of 44 patients, 42 (95.45%) who underwent the occipital nerve block procedure showed satisfactory results for at least 6 months. Mean headache VAS scores ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK580523/

Occipital Nerve Block - StatPearls - NCBI Bookshelf

Occipital neuralgia can mimic migraines, cluster headaches, and cervicogenic headaches, making an accurate diagnosis critical.

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05732532/steroids-in-occipital-nerve-block-for-treatment-of-headache

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, ...

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jofph.com

jofph.com/articles/10.22514/jofph.2024.010

Occipital nerve block for headaches: a narrative review

The occipital nerve block involves the injection of a local anesthetic and possibly a corticosteroid near the occipital nerves at the base of the skull.