NCT06937385

0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment

Randomized, Prospective, Open-label, Controlled Trial of 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications in Treatment of Non-Traumatic Headache in the Emergency Department

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: HCA Florida North Florida Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Headache
• Migraine
• Tension Headache
• Occipital Neuralgia

Interventions

Type	Name	Description
DRUG	0.5% Bupivacaine HCl	bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment
DRUG	standard IV treatment for headache	physicians choice of IV medications in treatment of headache

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-04-22
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study