Bupivacaine for Benign Headache in the ED



Status:Terminated
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:4/5/2019
Start Date:October 2013
End Date:July 2016

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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

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.

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. Additionally, most headache cocktails require prolonged duration of
treatment, occupying valuable bed space in increasingly busy emergency departments.

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. Since 2003, paraspinal muscle injections of bupivacaine have been used in
emergency department patients with encouraging results. The mechanism of action is not
clearly understood; however, it has been proposed that these injections affect the
trigeminocervical complex hypothesized to play an integral role in headache physiology,
similar to the same mechanism behind greater occipital nerve blocks used by neurologists.

To the best of the investigators knowledge, there has never been a prospective double-blinded
randomized control trial addressing this novel approach to headache management. Even so, the
topic of using bupivacaine to inject the paraspinal musculature of the cervical spine has
gained wider recognition over the past year. The topic has been discussed heavily on
emergency medicine blogs and podcasts. Additionally, online videos have been posted to
educate emergency medicine providers on the injection technique. According to retrospective
literature, clinical efficacy was observed with a significant proportion of the patients
receiving therapeutic effect. These studies, along with anecdotal experience with the
procedure at the investigators institution, have led to great excitement concerning the
possibility of a new approach to emergency department headache management. However, the topic
still needs investigation with a well-designed prospective clinical trial to determine true
clinical utility.

Inclusion Criteria:

1. Age 18-65 years old

2. Diagnosis of benign or primary headache

Exclusion Criteria:

1. Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine or
other drugs in the same class, dopaminergic blockers.

2. Overlying signs of infection at site of injection (Erythema, purulence, open skin)

3. Neck pathology ( History of surgery to the cervical spine, History of surgical
hardware in place, Documented disc abnormality, History of vertebral artery or carotid
artery dissection, Torticollis)

4. Intracranial abnormality/pathology (Tumor, Hemorrhage, Concussion or post concussive
syndrome)

5. History of increased intracranial pressure (ICP)

6. A known history of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia
or neuroleptic malignant syndrome

7. Known pregnancy

8. Narcotic seeking patients as determined by the treating physician with optional
assistance from medical record review and North Carolina Drug Database
We found this trial at
1
site
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Phone: 704-355-4288
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mi
from
Charlotte, NC
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