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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
HCA Florida North Florida Hospital
Study ID
NCT06937385
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Headache
  • Migraine
  • Occipital Neuralgia
  • Tension Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intravenous medication
    physicians choice of intravenous medication for headache treatment
  • Experimental: cervical IM injection
    bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location

Primary Outcome Measure

Visual analog scale pain score 0-10 [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HCA Florida north florida HospitalGainesvilleFlorida32605-

Find similar trials in Gainesville, FL

By condition
Migraine
By specialty
Neurology
By research site
HCA Florida north florida Hospital· Gainesville, FL

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