Bupivacaine for Benign Headache in the ED
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Purpose
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 1.5 ml sterile saline or 0.5% bupivacaine injected bilaterally in the paraspinal musculature of the cervical spine. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Headache |
Drug: 0.5% bupivacaine Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Benign Headache in the Emergency Department Population With Lower Cervical Paraspinous Bupivacaine Injections: Randomized Prospective Double-Blinded Control Trial |
- Symptomatic relief of headache [ Time Frame: 20 minutes post injection ] [ Designated as safety issue: No ]
Symptomatic relief of headache will be measured by:
Change from pre-intervention pain using a validated pain scale rating
- Headache relief
- Partial headache relief
- No headache relief
- Headache worsened
- Requirement for further treatment of headache in the emergency department prior to discharge (anti-emetics, NSAIDS, steroids, narcotics).
- Incidence of immediate and post-discharge complications. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Subjects will be monitored for both immediate and post discharge complications up to 72 hours after enrollment that include: persistent local pain, bleeding, infection, and inadvertent intravascular injection resulting in seizure or possible cardiovascular collapse.
- Headache recurrence [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Headache recurrence, measured by re-presentation within 72 hours of enrollment to healthcare provider upon chart review.
- Length of stay [ Time Frame: Participants will be followed for the duration of the Emergency Department visit, typically several hours ] [ Designated as safety issue: No ]Length of stay, measured by time from doctor encounter to disposition decision
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
sterile normal saline
|
Drug: placebo |
|
Experimental: treatment
0.5% bupivacaine
|
Drug: 0.5% bupivacaine
The injection site will be prepared using common sterile technique with 2% chlorahexadine. Either 1.5mL of sterile saline or 1.5mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-65 years old
- Diagnosis of benign or primary headache
Exclusion Criteria:
- Hypersensitivity or allergy to bupivacaine (amide anesthetics)
- Overlying signs of infection at site of injection (erythema, purulence, open skin)
- Cervical 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)
- Intracranial abnormality/pathology (tumor, hemorrhage, concussion or post concussive syndrome)
- History of increased intracranial pressure (ICP)
- Known pregnancy
- Narcotic seeking patients as determined by the treating physician with optional assistance from medical record review and North Carolina Drug Database
Contacts and Locations| Contact: Melanie M Hogg | 704-355-4288 | mhogg@carolinas.org |
| United States, North Carolina | |
| Carolinas Medical Center | Not yet recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Melanie M Hogg 704-355-4288 mhogg@carolinas.org | |
| Principal Investigator: | Sean Fox, MD | Carolinas Medical Center |
| Principal Investigator: | Greg Zahn, MD | Carolinas Medical Center |
More Information
No publications provided
| Responsible Party: | Sean Fox, Associate Professor, Carolinas Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01785459 History of Changes |
| Other Study ID Numbers: | BBH-001 |
| Study First Received: | February 3, 2013 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Carolinas Healthcare System:
|
headache migraine bupivacaine |
Additional relevant MeSH terms:
|
Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bupivacaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013