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临床试验/NCT06937385
NCT06937385尚未招募3 期

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

HCA Florida North Florida Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Visual analog scale pain score 0-10

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •traumatic headache
  • •Confused patients
  • •allergy to bupivacaine
  • •infection over injection site
  • •recent neck surgery
  • •hemodynamically unstable
  • •bleeding disorder
  • •anticoagulation use
  • •pregnant, lactating women
  • •prisoners

研究组 & 干预措施

Intravenous medication

Active Comparator

physicians choice of intravenous medication for headache treatment

干预措施: standard IV treatment for headache (Drug)

cervical IM injection

Experimental

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

干预措施: 0.5% Bupivacaine HCl (Drug)

结局指标

主要结局

Visual analog scale pain score 0-10

时间窗: 24 hours

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

次要结局

  • Need for additional medications(24 hours)
  • Emergency department length of stay(24 hours)

研究者

发起方
HCA Florida North Florida Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhengqiu Zhou

Faculty

HCA Florida North Florida Hospital

研究点 (1)

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