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0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06937385
Enrollment
100
Registered
2025-04-22
Start date
2025-05-01
Completion date
2026-05-01
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Migraine, Tension Headache, Occipital Neuralgia

Keywords

headache, bupivicaine, cervical injection, paraspinous injection

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.

Interventions

bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment

DRUGstandard IV treatment for headache

physicians choice of IV medications in treatment of headache

Sponsors

HCA Florida North Florida Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scale pain score 0-1024 hoursPain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.

Secondary

MeasureTime frameDescription
Emergency department length of stay24 hoursDuration that patients stayed in the Emergency department for
Need for additional medications24 hoursWhether an additional medication was given to patients after 30 minutes

Countries

United States

Contacts

Primary Contactzhengqiu zhou, MD
zhengqiu.zhou@icloud.com8593686486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026