0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.5% Bupivacaine HCl, standard IV treatment for headache.
- Who it may be relevant to
- Registry conditions: Headache, Migraine, Tension Headache, Occipital Neuralgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized, Prospective, Open-label, Controlled Trial of 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications in Treatment of Non-Traumatic Headache in the Emergency Department
Overview
Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.
Interventions
- Drug 0.5% Bupivacaine HCl
bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment - Drug standard IV treatment for headache
physicians choice of IV medications in treatment of headache
Primary outcome measures
- Visual analog scale pain score 0-10 [Time frame: 24 hours]
Secondary outcome measures (2)
- Emergency department length of stay [Time frame: 24 hours]
- Need for additional medications [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Patient has to be able to provide own consent
- English-speaking only
- Non traumatic headache with VAS pain score of 5 or above out of 10
Exclusion criteria
- traumatic headache
- Confused patients
- allergy to bupivacaine
- infection over injection site
- recent neck surgery
- hemodynamically unstable
- bleeding disorder
- anticoagulation use
- pregnant, lactating women
- prisoners
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- HCA Florida north florida Hospital — Gainesville
Identifiers
NCT: NCT06937385 · 2024-302