Bupivacaine for Benign Headache in the ED

NCT01785459 | Terminated Phase 2 Results

• 1 other identifier: BBH-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Headache

Keywords

headache; migraine; bupivacaine

Outcome Measures

Primary Outcomes (2)

• Length of Stay

  Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision

  enrollment day

• Incidence of Immediate and Post-discharge Complications.

  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.

  72 hours

Secondary Outcomes (1)

• Symptomatic Relief of Headache

  20 minutes

Study Arms (2)

standard care

ACTIVE COMPARATOR

intravenous Prochlorperazine

Drug: Standard Care

treatment

EXPERIMENTAL

0.5% bupivacaine

Drug: 0.5% bupivacaine

Interventions

0.5% bupivacaine DRUG

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.

treatment

Standard Care DRUG

10 mg Intravenous injection of Prochlorperazine

Also known as: Prochlorperazine, Reglan

standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Diagnosis of benign or primary headache

You may not qualify if:

• Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine or other drugs in the same class, dopaminergic blockers.
• Overlying signs of infection at site of injection (Erythema, purulence, open skin)
• 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)
• Intracranial abnormality/pathology (Tumor, Hemorrhage, Concussion or post concussive syndrome)
• History of increased intracranial pressure (ICP)
• A known history of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia or neuroleptic malignant syndrome
• Known pregnancy
• Narcotic seeking patients as determined by the treating physician with optional assistance from medical record review and North Carolina Drug Database

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Bupivacaine; Standard of Care; Prochlorperazine; Metoclopramide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Results Point of Contact

• Title: Dr. Sean Fox
• Organization: Carolinas Medical Center

Sean.Fox@atriumhealth.org

704-355-3181

Study Officials

• Sean Fox, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

• Carey Nichols, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2013
• First Posted: February 7, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 14, 2022
• Results First Posted: April 3, 2019

Record last verified: 2019-03

Locations

US (1)