跳至主要内容
临床试验/NCT02346929
NCT02346929招募中不适用

Comparison of Ultrasound-guided Hematoma Block and "Blind" Hematoma Block for Analgesia in Distal Radius Fractures

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
115
试验地点
1
主要终点
Pain Reduction as indicated by Visual Analog Scale

研究概览

简要总结

The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.

详细描述

Hematoma blocks are safe and effective in providing analgesia for fracture reduction1-4. They involve injecting lidocaine directly into the fracture line for analgesia. The physician aspirates blood prior to injection to confirm placement in the hematoma created by the fracture. However, the procedure can be technically difficult if the fracture line is difficult to palpate, for example, due to significant swelling or body habitus. Ultrasound has been shown to improve efficacy in other analgesic procedures such as peripheral nerve blocks5 and also in identifying fracture lines6. There have been case reports and case series which have shown the feasibility and effectiveness of ultrasound guided hematoma blocks for analgesia in patients undergoing reduction for distal radius fractures7,8. To our knowledge there are no randomized controlled trials comparing the use of ultrasound guided hematoma blocks versus traditional hematoma blocks in achieving analgesia for distal radius fracture reduction.

In this study, we will determine if ultrasound improves the efficacy of analgesia when performing hematoma blocks for reduction of distal radius fractures.

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

入选标准

  • Adult patient ≥ 18 years old presenting to the emergency department with complaint of distal radius fracture

排除标准

  • High acuity/distress per the Attending ED physician
  • Altered mental status or intoxication
  • Aphasia, mental retardation, dementia, or insurmountable communication barrier
  • Acute psychiatric illness

研究组 & 干预措施

ultrasound-guided hematoma block

Experimental

Patients in this arm will receive a bed-side ultrasound guided hematoma block with analgesia (0.25% bupivacaine)

干预措施: ultrasound guide (Other)

traditional hematoma block

No Intervention

Patients in this arm will have the hematoma block of the distal radius fracture with no ultrasound for guidance with analgesia (0.25% bupivacaine)

结局指标

主要结局

Pain Reduction as indicated by Visual Analog Scale

时间窗: 4 hours after initiation of study procedure

Subjects will be surveyed on a Visual Analog Scale (VAS) on their pain during 4 points: prior to receiving hematoma block, after receiving hematoma block, during reduction and prior to discharge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beatrice Hoffmann

ED Faculty

Beth Israel Deaconess Medical Center

研究点 (1)

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