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NCT Number: NCT06937385

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

HCA Florida north florida Hospital

Gainesville, Florida, 32605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5% Bupivacaine HCL

Drug

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

Other names: cervical IM injection

standard IV treatment for headache

Drug

physicians choice of IV medications in treatment of headache

Primary outcomes

  1. Visual analog scale pain score 0-10

    Time frame: 24 hours

    Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.

Secondary outcomes

  1. Emergency department length of stay

    Time frame: 24 hours

    Duration that patients stayed in the Emergency department for

  2. Need for additional medications

    Time frame: 24 hours

    Whether an additional medication was given to patients after 30 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

zhengqiu zhou, MD

CONTACT

[email protected]

8593686486

Sponsors and collaborators

Lead sponsor

HCA Florida North Florida Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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