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临床试验/NCT01294098
NCT01294098终止不适用

Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Post-operative Pain Scores

研究概览

简要总结

The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

详细描述

Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
  • Weight of 30-100 Kg
  • Child must be older than 6 years old

排除标准

  • Any child that had an open fracture
  • A child that has a pain abnormality
  • Any child with an allergy to local anesthetic
  • Any child with a neurological injury
  • Any child with the inability to report pain
  • Any child that is unable to use a PCA post-operatively

研究组 & 干预措施

PCA and femoral nerve block

Experimental

this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively

干预措施: Marcaine (Drug)

PCA + hematoma block

Experimental

patient will receive hematoma block during surgery

干预措施: Marcaine (Drug)

结局指标

主要结局

Post-operative Pain Scores

时间窗: with in the first 24 hours

We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. Hurts worst

Post-operative Narcotic Use

时间窗: within first 24 horus

We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use

次要结局

  • Femur Fracture Healing(first year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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