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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. 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 non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.

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 bupivacaine generally safe for use in humans?

Bupivacaine is generally considered safe when used correctly, but it can cause serious side effects like seizures and heart problems if too much is absorbed into the body. Studies show that careful application and proper dosing are important to avoid these risks. ^{1 2 3 4 5}

How does the drug Bupivacaine Injection for Headache differ from other treatments for headaches?

Bupivacaine Injection for Headache is unique because it involves the use of a local anesthetic (a drug that causes loss of feeling in a small area) to potentially relieve headache pain, which is different from the typical use of triptans like sumatriptan or zolmitriptan that target serotonin receptors to treat migraines. This approach may offer an alternative for patients who do not respond well to traditional migraine medications. ^{6 7 8 9 10}

Research Team

Robyn Hoelle, MD

Principal Investigator

HCA north florida hospital emergency department

Eligibility Criteria

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

My blood pressure and circulation are not stable.

Pregnant or lactating women

Confused patients

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

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

The safety of liposome bupivacaine, a novel local analgesic formulation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and pharmacodynamics of liposome bupivacaine administered via a single epidural injection to healthy volunteers. [2022]

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

Bupivacaine-induced seizures and ventricular fibrillation in a 13-year-old girl undergoing wound debridement. [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

[The problem of the cardiotoxicity of bupivacaine 0.75%]. [2013]

5. Germany pubmed.ncbi.nlm.nih.gov

[A clinical study of circulatory depression and pharmacokinetics following peridural anesthesia with bupivacaine 0.75%. Preoperative phase]. [2013]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of acute migraine with subcutaneous GR43175 in West Germany. [2017]

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

The thigh may not be suitable as an injection site for patients self-injecting sumatriptan. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Zolmitriptan (Zomig, 311C90), a novel dual central and peripheral 5HT1B/1D agonist: an overview of efficacy. [2017]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Needle-free subcutaneous sumatriptan: in the acute treatment of migraine attacks or cluster headache episodes. [2021]