The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics
2019年11月3日 更新者：Mansoura University
The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.
The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.
研究概览
地位
完全的
详细说明
The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
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
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DK
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Mansourah、DK、埃及、050
- Mansoura University, Faculty of Medicine
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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
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- American Society of Anesthesiologists physical class I or II
Exclusion Criteria:
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases
- Bleeding disorders
- Coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
- Sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Bilateral upper limb injury to be performed at the same procedure.
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Warm bupivacaine at (37°c)
Warmed bupivacaine at body temperature will be administered
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Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes.
The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
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有源比较器：Bupivacaine at operating room temperature (23°c)
Bupivacaine at temperature of 23°C will be administered
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Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C.
The empty syringes and needles will be held in the same temperature before use.
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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 |
|---|---|---|
|
Time to onset of sensory block
大体时间：for 30 min following injection
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defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)
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for 30 min following injection
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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 to onset of motor block
大体时间：For 3 hours after the injection of local anesthetic
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defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.
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For 3 hours after the injection of local anesthetic
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Heart rate
大体时间：For 3 hours after the injection of local anesthetic
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For 3 hours after the injection of local anesthetic
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Blood pressure
大体时间：For 3 hours after the injection of local anesthetic
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For 3 hours after the injection of local anesthetic
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oxygen saturation in the peripheral blood
大体时间：For 3 hours after the injection of local anesthetic
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For 3 hours after the injection of local anesthetic
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|
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Duration of sensory block
大体时间：For 24 hours after the injection of local anesthetic
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defined as the interval between end of injection and complete end of sensory block (score=2)
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For 24 hours after the injection of local anesthetic
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|
Duration of motor block
大体时间：For 24 hours after the injection of local anesthetic
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defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.
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For 24 hours after the injection of local anesthetic
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The severity of postoperative pain
大体时间：For 24 hours after the injection of local anesthetic
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will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.
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For 24 hours after the injection of local anesthetic
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Time for first analgesic request
大体时间：For 24 hours after the injection of local anesthetic
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Time to the first receiving of rescue analgesic from the time of blockade
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For 24 hours after the injection of local anesthetic
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Total analgesics received
大体时间：for 24 hrs after the injection of local anesthetic
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Cumulative use of rescue analgesics after performing the blockade
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for 24 hrs after the injection of local anesthetic
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Satisfaction Score
大体时间：for 48 hrs after the injection of local anesthetic
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Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
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for 48 hrs after the injection of local anesthetic
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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
- 学习椅：Mohamed Y Makharita, MD、Professor of Anesthesia and Surgical Intensive Care
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 (实际的)
2017年10月1日
初级完成 (实际的)
2018年6月9日
研究完成 (实际的)
2018年9月17日
研究注册日期
首次提交
2017年8月25日
首先提交符合 QC 标准的
2017年8月25日
首次发布 (实际的)
2017年8月29日
研究记录更新
最后更新发布 (实际的)
2019年11月6日
上次提交的符合 QC 标准的更新
2019年11月3日
最后验证
2019年11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.
Warm bupivacaine at (37°c)的临床试验
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AstraZenecaParexel完全的
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The First Affiliated Hospital of Soochow University招聘中