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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHCA Florida North Florida Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

traumatic headache

Confused patients

allergy to bupivacaine

infection over injection site

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.5% Bupivacaine HCl

    Drug

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

  • standard IV treatment for headache

    Drug

    physicians choice of IV medications in treatment of headache

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intravenous medicationActive comparator 1 intervention
Group B: cervical IM injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual analog scale pain score 0-10

Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.

Time frame
24 hours

Secondary outcomes

1

Emergency department length of stay

Duration that patients stayed in the Emergency department for

Time frame
24 hours
2

Need for additional medications

Whether an additional medication was given to patients after 30 minutes

Time frame
24 hours

Other outcomes

Sponsors and contacts

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