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Terminated Phase 2 Interventional Results available

Bupivacaine for Benign Headache in the ED

ClinicalTrials.gov ID: NCT01785459

Public ClinicalTrials.gov record NCT01785459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Treatment of Benign Headache in the Emergency Department Population With Lower Cervical Paraspinous Bupivacaine Injections Versus Anti-Emetic Treatment in the Emergency Department Population: Randomized Prospective Control Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01785459
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Enrollment
23 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2013
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016
Last update posted
Jul 13, 2022

2013 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Carolinas Medical Center Charlotte North Carolina 28203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01785459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 13, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01785459 live on ClinicalTrials.gov.

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