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NCT01785459 · ClinicalTrials.gov registry record · Phase 2
Bupivacaine for Benign Headache in the ED
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01785459 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 23 participants.
The verdict
NCT01785459, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
Headache is a common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. By the time patients with benign headaches arrive in the emergency department, they have often failed non-invasive therapeutic attempts and providers are often left with few therapeutic options. Treatment of benign headache varies between providers, often including systemic medications with a multitude of possible side effects. In recent years, there has been preliminary investigation into anesthetic injections for the undifferentiated headache patient presenting to the emergency department. It has been proposed that these patients presenting with benign headache might benefit from this novel treatment. Patients that present to the Emergency Department with a diagnosis of benign or primary headache with serious or life-threatening causes of headache will be offered enrollment into the study. Following consent, subjects will receive either 0.5% bupivacaine injected bilaterally in the paraspinal musculature of the cervical spine or the standard treatment with intravenous Prochlorperazine. The subjects will complete a validated pain scale before, and 20 minutes after injection. At twenty minutes post-injection, the subject will be reevaluated for symptoms. The subject will then be eligible for discharge or standard treatment at the discretion of the treating physician. Subjects will be followed for 72 hours after enrollment for headache recurrence. Subjects will be monitored for immediate and post-discharge complications.
Interventions
- DRUG 0.5% bupivacaine
- DRUG Standard Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01785459
The ClinicalTrials.gov registry entry for NCT01785459 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 0.5% bupivacaine is the first listed.
NCT01785459 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01785459 about?
NCT01785459 is a clinical study titled "Bupivacaine for Benign Headache in the ED". Headache is a common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. By the time patients with benign headaches arrive in the emerg...
What is the current status of trial NCT01785459?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2013-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01785459?
The interventions under investigation include: 0.5% bupivacaine (DRUG), Standard Care (DRUG).
Who is sponsoring clinical trial NCT01785459?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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