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

HCA Florida North Florida Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Occipital Neuralgia; Tension Headache; Migraine; Headache

Treatments: Drug: 0.5% Bupivacaine HCl; Drug: standard IV treatment for headache

Study type: Interventional

Funder types: Other

Identifiers

NCT06937385

2024-302

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has to be able to provide own consent
• English-speaking only
• Non traumatic headache with VAS pain score of 5 or above out of 10

Exclusion criteria

• traumatic headache
• Confused patients
• allergy to bupivacaine
• infection over injection site
• recent neck surgery
• hemodynamically unstable
• bleeding disorder
• anticoagulation use
• pregnant, lactating women
• prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intravenous medication

Active Comparator group

Description:

physicians choice of intravenous medication for headache treatment

Treatment:

Drug: standard IV treatment for headache

cervical IM injection

Experimental group

Description:

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

Treatment:

Drug: 0.5% Bupivacaine HCl