Obturator Nerve Block in Patients With Hip Fracture (OPAD)
Proximal Obturator Nerve Block After Insufficient Analgesic Effect of Femoral Nerve Block in Patients With Hip Fracture
About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves occasionally are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.
The aim of this trail is to give patients with hip fracture and only insufficient effect of a femoral nerve block a supplementary obturator nerve block in a randomized manner with either local anesthetics or placebo in order to access the preoperative analgesic effect.
研究概览
详细说明
About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves occasionally are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block af the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trail is to give patients with hip fracture and only insufficient effect of a femoral nerve block a supplementary obturator nerve block in a randomized manner with either local anesthetics or placebo in order to access the preoperative analgesic effect.
研究类型
阶段
- 第四阶段
联系人和位置
学习地点
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-
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Aarhus、丹麦、8000
- Aarhus University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical suspicion of hip fracture
- Successful sensory cutaneous effect of the femoral nerve block
- Age ≥ 55 years
- Mentally capable of comprehending and using verbal pain score
- Mentally capable of differentiating between pain from the fractured hip and pain from other locations
- Mentally capable of understanding the given information
- Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
- Possible sonographic visualization of the structures needed for the nerve block
- Verbal numeric pain scale score (NRS 0-10) > 5 with passive leg raise of the fractured leg at the time of inclusion OR NRS > 3 at rest, 30 minutes after a femoral nerve block
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 45 kg
- Patient has previously been included in this trial
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
- Visible infection in the area of the point of needle injection
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Local anesthetic
15 ml. of local anesthetic
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Bupivacaine is injected proximally to anesthetize the obturator nerve
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安慰剂比较:Saline
15 ml. of saline
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Saline is injected as a placebo
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Success rate of successful analgesia
大体时间:20 minutes
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Success rate of successful analgesia 20 minutes after a supplementary obturator nerve block in patients with hip fracture
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20 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time used for the procedure
大体时间:Expected average of 5 minutes
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Time from start of ultrasound scanning to end of injection of local anesthetic or placebo
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Expected average of 5 minutes
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Success rate of possible sonographic visualization
大体时间:Expected average of 5 minutes
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Success rate of possible sonographic visualization of necessary anatomical structures i order to do the nerve block
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Expected average of 5 minutes
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Time to analgesia
大体时间:20 minutes
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Time from end of injection of local anesthetic to analgesia
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20 minutes
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合作者和调查者
调查人员
- 研究主任:Thomas F. Bendtsen, MD, Ph.d.、Aarhus University Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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