Clinical trial NCT06937385: 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Headache
Migraine
Tension Headache
Occipital Neuralgia
Keywords: headache
bupivicaine
cervical injection
paraspinous injection
Lead sponsor: HCA Florida North Florida Hospital
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Visual analog scale pain score 0-10
timeFrame: 24 hours
Secondary outcomes:
measure: Emergency department length of stay
timeFrame: 24 hours
measure: Need for additional medications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: HCA Florida north florida Hospital
state: Florida
Study officials:
affiliation: HCA north florida hospital emergency department
name: Robyn Hoelle, MD
role: PRINCIPAL_INVESTIGATOR
References: