Bupivacaine Injection for Headache

Overseen By zhengqiu zhou, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: HCA Florida North Florida Hospital

Must not be taking: Anticoagulants

Disqualifiers: Traumatic headache, Confusion, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new method for treating non-traumatic headaches that don't respond well to over-the-counter medication. Researchers compare a bupivacaine injection, a local anesthetic, into the neck muscles with the usual IV medicines given in the ER. They aim to determine if the injection works as well or better, with fewer side effects. Individuals with regular headaches scoring 5 or higher on a pain scale, who can provide their own consent, might be suitable for this study. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using anticoagulants (blood thinners), you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, most patients who received bupivacaine injections for headaches experienced relief for at least 24 hours. This finding suggests that bupivacaine can help manage pain. Another study showed a significant reduction in pain levels after treatments that block nerve signals, often using bupivacaine.

Bupivacaine works by stopping nerve signals that cause pain. It is usually well-tolerated, but like any medication, it can have side effects. Some individuals might experience temporary numbness or tingling at the injection site.

Since this trial is in a late stage, evidence should already indicate that bupivacaine is safe for humans. Additionally, bupivacaine is already used for other types of pain management, supporting its safety. However, always discuss potential risks and benefits with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for headaches?

Researchers are excited about using 0.5% bupivacaine injections for headaches because it offers a unique delivery method compared to standard treatments like oral medications or intravenous drugs. Unlike typical headache treatments that are taken by mouth or through an IV, bupivacaine is injected directly into the neck muscles (cervical IM injection), potentially providing faster and more targeted pain relief. This novel approach could mean quicker relief for patients by directly addressing the source of the headache pain, which is a significant advantage over traditional methods.

What evidence suggests that this trial's treatments could be effective for headaches?

Research has shown that bupivacaine injections in the lower neck can relieve headaches. In past studies, 65.1% of patients experienced complete relief from headaches after these injections. In this trial, one group of participants will receive bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the C6-7 location. This treatment aims to quickly reduce pain with fewer side effects than standard treatments. This method could offer a promising option for those seeking fast headache relief without the usual risks of medication. ^{6 7 8 9 10}

Who Is on the Research Team?

Robyn Hoelle, MD

Principal Investigator

HCA north florida hospital emergency department

Are You a Good Fit for This Trial?

This trial is for individuals who visit the Emergency Department with various types of headaches, such as tension headaches or migraines, and have not found relief from over-the-counter remedies. Participants should be seeking an alternative to standard IV headache treatments.

Inclusion Criteria

English-speaking only

I can make my own medical decisions.

I have severe headaches with a pain score of 5 or more.

Exclusion Criteria

Pregnant or lactating women

My blood pressure and circulation are not stable.

Confused patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 0.5% bupivacaine cervical IM injection or physician's choice of intravenous medications for headache treatment

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain score assessment at 30 minutes and 24 hours

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• 0.5% Bupivacaine HCl

Trial Overview The study is testing if injecting a drug called Bupivacaine into muscles in the lower neck works as well as usual IV drugs for treating headaches. It's a randomized trial comparing these two methods directly at North Florida Hospital.

How Is the Trial Designed?

Group I: cervical IM injection Experimental Treatment 1 Intervention

bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location

Group II: Intravenous medication Active Control 1 Intervention

physicians choice of intravenous medication for headache treatment

Who Is Running the Clinical Trial?

HCA Florida North Florida Hospital

Lead Sponsor

Published Research Related to This Trial

In a study involving 823 patients across various surgical settings, liposome bupivacaine demonstrated a lower incidence of adverse events (62%) compared to bupivacaine HCl (75%) and placebo (43%), indicating better tolerability.

Serious adverse events were less common in the liposome bupivacaine group (2.7%) compared to bupivacaine HCl (5.4%), suggesting that liposome bupivacaine may be a safer option for local analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. Viscusi, ER., Sinatra, R., Onel, E., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17040341/

Treatment of headaches in the ED with lower cervical ... Results: Lower cervical paraspinous intramuscular injections with bupivacaine were performed in 417 patients. Complete headache relief occurred in 271 (65.1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06937385?cond=%22Tension%20Headache%22&aggFilters=status:not%20rec&rank=1

0.5% Bupivacaine Lower Cervical Intramuscular Injection ... The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a ...

3. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/abs/10.1111/j.1526-4610.2006.00586.x

Treatment of Headaches in the ED With Lower Cervical ... —Lower cervical paraspinous intramuscular injections with bupivacaine were performed in 417 patients. Complete headache relief occurred in 271 ( ...

4. papers.mrotte.com papers.mrotte.com/headache_inject.pdf

Treatment of Headaches in the ED With Lower Cervical ... The intramuscular injection of 1.5 mL of 0.5% bupivacaine bilateral to the sixth or seventh cervical vertebrae has been used to treat headache pain in our ...

5. jofph.com jofph.com/articles/10.11607/jofph.22.1.07

Treatment of Acute Orofacial Pain with Lower Cervical ... The findings suggest that lower cervical paraspinous intramuscular injections with bupivacaine may prove to be a new therapeutic option for acute orofacial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380438/

Assessing the effectiveness of greater occipital nerve block in ... Primary efficacy outcomes included headache frequency, duration, and intensity along with safety assessments. Results. Literature searches ...

7. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.15001

A retrospective cohort study to evaluate the effectiveness and ... Participants receiving nerve blocks noted a reduction in pain on a visual analog scale from an average of 7 to 2 (p < 0.001) as well as from 9 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5830113/

Patterns of Use of Peripheral Nerve Blocks and Trigger Point ... Ninety-three percent of subjects reported a good outcome, defined as headache improvement for at least 24 hours or sufficient improvement to ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/bupivacaine-injection-route/description/drg-20406723

Bupivacaine (injection route) - Side effects & uses Bupivacaine injection causes a loss of feeling and prevents pain by blocking signals at the nerve endings. It does not cause loss of ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf

Bupivacaine Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL ...