NCT06937385Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 15 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- HCA Florida North Florida Hospital
- Diseases
- Migraine
- NCT number
- NCT06937385
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 1 May 2025 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- recent neck surgery
Other illness
- allergy to bupivacaine
- infection over injection site
- bleeding disorder
Other
- traumatic headache
- Confused patients
- hemodynamically unstable
- anticoagulation use
- pregnant, lactating women
- prisoners
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HCA Florida north florida Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.