Intranasal Nerve Block for Headache

Overseen By John B Terry, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wright State University

Disqualifiers: Under 18, Allergy to lidocaine, Vulnerable groups, Hunt and Hess 4-5, Unable to consent, Prisoners, Pregnant, Nose bleeds, Nasal deformity, Recent nasal surgery, Bleeding disorder, Severe respiratory distress, Nasal tumor, Nasal trauma, Nasal congestion, 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: 2

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with severe headaches caused by bleeding from a brain aneurysm. The study tests a nasal spray pain treatment (intranasal lidocaine) that targets a specific nerve bundle linked to head pain, aiming to reduce pain without the usual side effects of standard pain medications. Participants will receive this nasal treatment alongside their regular pain medications, and researchers will monitor its impact on pain levels and medication needs. It suits patients who have experienced brain bleeding and can report their headaches, but not those with certain nasal issues or allergies to the medication. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you will continue to receive standard pain medicine as needed for your headache during the study.

What is the safety track record for this treatment?

Research has shown that intranasal lidocaine is generally well-tolerated. In studies, up to 49.4% of participants experienced nasal irritation. However, no major adverse events occurred. Other common side effects included a change in taste and mild nasal discomfort, which appeared more frequently in those who received the treatment compared to those who did not.

The treatment is already used for sudden migraines, indicating its safety for similar conditions. While some side effects are common, the treatment lacks the serious risks associated with standard pain medications. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about intranasal lidocaine for headaches because it offers a unique delivery method compared to standard oral or intravenous treatments. Unlike traditional pain relief medications that can take time to circulate through the body, administering lidocaine intranasally allows for rapid action directly at the nerve pathways involved in headache pain. This approach could lead to faster relief with potentially fewer systemic side effects.

What evidence suggests that intranasal lidocaine might be an effective treatment for headache?

Research has shown that using lidocaine in a nasal spray can help with headaches. In one study, 35.8% of participants felt relief within 15 minutes of using the spray. Another study found that individuals with sudden migraines experienced less pain after using this treatment. Although some debate exists about its overall effectiveness, these studies suggest that the nasal spray could reduce headache pain. Participants in this trial will receive intranasal lidocaine, which avoids the side effects often associated with regular pain medications. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients who have had a brain aneurysm bleed and suffer from severe headaches. It's designed to help those who haven't found relief with standard pain medications, which often have side effects like sedation or addiction risks.

Inclusion Criteria

I am 18 or older, in the ICU for a brain bleed, and can talk about my headache.

Exclusion Criteria

Pregnant patients

I am under 18 years old.

Patients that are prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive intranasal sphenopalatine ganglion blockade treatment on Day 1 and Day 4, with pain recorded every 8 hours until discharge

2 weeks

Daily monitoring (in-person)

Follow-up

Participants are contacted by phone to assess head pain 6 months after discharge

6 months

1 visit (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Intranasal Lidocaine

Trial Overview The study tests a nasal spray treatment using Lidocaine to block the sphenopalatine ganglion, which could reduce headache pain without typical medication side effects. Patients will receive this alongside standard pain meds and their usage of both will be compared before and after treatment.

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 2 Interventions

Treatment arm

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11279969/

Intranasal lidocaine for migraine: a randomized trial and ... Results: In the controlled trial, headache was relieved within 15 minutes in 34 (35.8%) of 95 subjects treated with 4% intranasal lidocaine compared with 8 ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0224285

Intranasal lidocaine for acute migraine: A meta-analysis of ... The results of the present review indicated that the group of patients with acute migraines who received intranasal lidocaine had less pain ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2019/05170/intranasal_lidocaine_for_acute_migraine__a.85.aspx

Intranasal lidocaine for acute migraine Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5703756/

Intranasal Lidocaine for Primary Headache Management in ... They found that headache was relieved within 15 min in 35.8% of patients in the treatment group, with a 20.6% relapse rate (12).

5. practicalneurology.com practicalneurology.com/diseases-diagnoses/headache-pain/intranasal-acute-migraine-treatments/32128/

Intranasal Acute Migraine Treatments - - Practical Neurology Reported outcomes from this trial were pain freedom at 2 hours in 38.0% and pain freedom at 2 hours for doses of Trudehsa taken 2 hours after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6808552/

Intranasal lidocaine for acute migraine: A meta-analysis of ... Using lidocaine caused local irritation in up to 49.4% of the patients in one report but did not cause major adverse events. Conclusion.

7. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-023-01662-6

Efficacy and safety of intranasal agents for the acute treatment ... ROX-828, composed of 31.5 mg ketorolac with 6% lidocaine, was evaluated for efficacy and safety in the acute treatment of migraine. Compared to ...