NCT00175591已完成1 期
The Effect of Femoral Nerve Block on Opioid Requirements Following Femoral Fracture Fixation With Flexible Nails in the Paediatric Population: A Double Blind, Prospective Randomized Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
研究概览
简要总结
This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femoral shaft fracture requiring intra-medullary nailing
- •Surgery performed within 24 hours of injury
- •Ability of child or family to use patient-controlled analgesia (PCA)
- •No allergy or sensitivity to bupivacaine
- •Informed consent and assent
排除标准
- •Open femur fractures
- •Closed fractures needing open reduction
- •Fractures associated with neurovascular complications
- •Fractures associated with compartment syndrome
- •Repeat femoral surgeries
- •Patients who received a femoral nerve block more than 1 hour prior to surgery
- •Complex associated injuries or pre-existing condition that will delay time to ambulation
- •Children who are allergic and/or sensitive to bupivacaine
结局指标
主要结局
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
时间窗: until patient discharge
次要结局
- Pain rating(immediately post-op)
- Time (hours) from end of surgery to sitting on bed with legs hanging over the side
- Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate(every 8 hours)
- Time to discharge(from end of surgery)
研究者
Kishore Mulpuri
Principle Investigator
University of British Columbia
研究点 (2)
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