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临床试验/NCT03625076
NCT03625076Unknown4 期

Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations

Kendall Healthcare Group, Ltd.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
70
试验地点
1
主要终点
Emergency Department Length of Stay

研究概览

简要总结

This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.

详细描述

This will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ED with anterior shoulder dislocations. This study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ED with an anterior shoulder dislocation as determined by the ED physician. Written, informed consent will be obtained from each patient. After enrollment, each patient will be randomized either to IV sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. Randomization will be done before the initiation of data collection, and will be done with a random number generator. Patients who are randomized to the intra-articular group will receive 20 mL of 1% lidocaine injected into the glenohumeral joint using a lateral approach. Treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. The primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18-70 years old in the emergency department with an anterior shoulder dislocation.

排除标准

  • Pregnant or breastfeeding
  • Is a prisoner.
  • Known allergy to one of the study drugs.
  • Altered mental status.
  • Shoulder fracture (other than a Hill-Sachs) associated with the dislocation.
  • Attending provider excludes patient.

研究组 & 干预措施

Intra-articular Lidocaine

Experimental

20 mL of 1% lidocaine injected into the joint of the dislocated shoulder

干预措施: Intra-articular Lidocaine (Drug)

Procedural Sedation

Active Comparator

Intravenous etomidate or propofol

干预措施: Procedural Sedation with etomidate or propofol (Drug)

结局指标

主要结局

Emergency Department Length of Stay

时间窗: Anticipated 1-4 hours

The elapsed time over which the patient is physically in the emergency department

次要结局

  • Number of Reduction Attempts(Each attempt takes under 5 minutes)
  • Patient Satisfaction(The patient is asked their satisfaction just prior to discharge (generally within 4 hours))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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