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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for headaches?

Research shows that blocking the greater occipital nerve, often with steroids, can help relieve pain in various types of headaches, including migraines and cluster headaches. Studies have found that these nerve blocks can be beneficial for patients, providing pain relief and helping manage headache symptoms. ^{1 2 3 4 5}

Is the steroid occipital nerve block generally safe for humans?

Occipital nerve blocks, which may include steroids like dexamethasone, are generally considered safe, but there are some risks. In a study, only 3% of patients reported minor adverse reactions, but rare cases of temporary facial nerve palsy and infection have been reported. Additionally, repeated use of steroid-containing blocks can lead to Cushing syndrome, a condition caused by high levels of steroids in the body. ^{6 7 8 9 10}

How is the steroid occipital nerve block treatment for headaches different from other treatments?

The steroid occipital nerve block treatment is unique because it involves injecting steroids and sometimes local anesthetics directly into the occipital nerve, which can provide targeted relief for headaches. This method is different from oral medications as it delivers the treatment directly to the nerve area, potentially offering faster and more localized pain relief. ^{2 3 4 11 12}

Research Team

Carrie Robertson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of greater occipital nerve block for pain relief in patients with postdural puncture headache: A meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. [2017]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Transient facial nerve palsy after occipital nerve block: a case report. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Occipital osteomylelitis and epidural abscess after occipital nerve block: A case report. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Ultrasound-guided greater occipital nerve block for patients with occipital headache and short term follow up. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cushing syndrome induced by serial occipital nerve blocks containing corticosteroids. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Orgasmic headache responsive to greater occipital nerve blockade. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Treatment of migraine with occipital nerve blocks using only corticosteroids. [2013]