Bupivacaine for Benign Headache in the ED
Condition: Benign Headache
MeSH terms: Headache
Intervention: 0.5% bupivacaine; Standard Care
Intervention description: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL 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.; 10 mg Intravenous injection of Prochlorperazine
Intervention MeSH terms: Prochlorperazine; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: headache; migraine; bupivacaine

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.
    

Eligibility criteria:

        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