此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Obturator Nerve Block in Patients With Hip Fracture (OPAD)

2015年9月11日 更新者:University of Aarhus

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

地位

撤销

条件

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

介入性

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Aarhus、丹麦、8000
        • Aarhus University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Local anesthetic
15 ml. of local anesthetic
Bupivacaine is injected proximally to anesthetize the obturator nerve
安慰剂比较:Saline
15 ml. of saline
Saline is injected as a placebo
其他名称:
  • 氯化钠溶液

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
Success rate of successful analgesia 20 minutes after a supplementary obturator nerve block in patients with hip fracture
20 minutes

次要结果测量

结果测量
措施说明
大体时间
Time used for the procedure
大体时间:Expected average of 5 minutes
Time from start of ultrasound scanning to end of injection of local anesthetic or placebo
Expected average of 5 minutes
Success rate of possible sonographic visualization
大体时间:Expected average of 5 minutes
Success rate of possible sonographic visualization of necessary anatomical structures i order to do the nerve block
Expected average of 5 minutes
Time to analgesia
大体时间:20 minutes
Time from end of injection of local anesthetic to analgesia
20 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年3月1日

初级完成 (预期的)

2016年12月1日

研究完成 (预期的)

2017年3月1日

研究注册日期

首次提交

2015年3月31日

首先提交符合 QC 标准的

2015年4月2日

首次发布 (估计)

2015年4月3日

研究记录更新

最后更新发布 (估计)

2015年9月14日

上次提交的符合 QC 标准的更新

2015年9月11日

最后验证

2015年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅