Obturator and Femoral Nerve Block in Patients With Hip Fracture
Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves 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 trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
研究概览
详细说明
A higher number than expected 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 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 of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Aarhus、丹麦、8000
- 招聘中
- Aarhus University Hospital
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接触：
- Thomas D. Nielsen, MD
- 电话号码：+45 28782877
- 邮箱：thomas.dahl.nielsen@clin.au.dk
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接触：
- Thomas F. Bendtsen, MD, Ph.d.
- 电话号码：+45 51542997
- 邮箱：tfb@dadlnet.dk
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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
- 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
- Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 40 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：Bupivacaine
Obturator nerve block
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Obturator nerve block
其他名称：
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安慰剂比较：Saline
Saline is injected as a placebo
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Obturator nerve block with saline(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 |
|---|---|---|
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Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
大体时间：30 minutes
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Success rate of successful analgesia compared between the groups
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30 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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Median pain score (NRS 0-10)
大体时间：30 minutes
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Median pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
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Median change in pain score (NRS 0-10)
大体时间：30 minutes
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Median change in pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
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Course in pain reduction
大体时间：30 minutes
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Course in pain reduction during the 30 minutes after the nerve blocks
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30 minutes
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Time to sufficient analgesia
大体时间：30 minutes
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Time from ended injection until sufficient analgesia
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30 minutes
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Frequency of anesthesia in the skin area of the saphenous nerve
大体时间：30 minutes
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Frequency of anesthesia in the skin area innervated by the saphenous nerve
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30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
大体时间：30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
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30 minutes
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Localization of the worst pain before block
大体时间：0 minutes
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Localization of the worst pain before any nerve blocks
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0 minutes
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Localization of the worst pain after block
大体时间：30 minutes
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Localization of the worst pain 30 minutes after the nerve blocks
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30 minutes
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Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
大体时间：5 minutes
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Discomfort during the nerve block procedures compared between procedures
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5 minutes
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Satisfaction (0-10, 0= very unsatisfactory)
大体时间：30 minutes
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Patient satisfaction with the pain treatment
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30 minutes
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Frequency of ultrasound visualization of femoral nerve
大体时间：5 minutes
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Frequency of patients with possible ultrasound visualization af the femoral nerve
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5 minutes
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Frequency of ultrasound visualization of obturator injection site
大体时间：5 minutes
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Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
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5 minutes
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Time spend on femoral nerve block
大体时间：5 minutes
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Time spend on conducting the femoral nerve block
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5 minutes
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Time spend on obturator nerve block
大体时间：5 minutes
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Time spend on conducting the obturator nerve block
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5 minutes
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Total morphine equivalent dose of opioid from the time of nerve block to operation
大体时间：Approximately 24 hours in average
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Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block to operation
大体时间：Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid in the first 10 hours after nerve block
大体时间：10 hours
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Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
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10 hours
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Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
大体时间：10 hours
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Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
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10 hours
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合作者和调查者
调查人员
- 研究主任：Thomas F. Bendtsen, Ph.d.、Aarhus University Hospital
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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