Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block
Perineural Dexmedetomidine vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.
研究概览
地位
详细说明
This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Wielkopolska
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Poznan、Wielkopolska、波兰、61-545
- Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
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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:
- children scheduled for foot/ankle surgery
- body weight > 5kg
Exclusion Criteria:
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
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 |
|---|---|
|
安慰剂比较：Sham Block
0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
其他名称：
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有源比较器：Dexamethasone
0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block |
|
有源比较器：Dexmedetomidine
0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block |
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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time to the first need of opiate following the procedure
大体时间：within 48 hours
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Time after surgery when the patient needs opiate for the first time |
within 48 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：4 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
4 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：6 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
6 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：8 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
8 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：12 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
12 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：16 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
16 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：20 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
20 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：24 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
24 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：36 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
36 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
大体时间：48 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
48 hours
|
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Neutrophil-to-lymphocyte ratio
大体时间：24 hours after surgery
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Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample. |
24 hours after surgery
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Platelet-to-lymphocyte ratio
大体时间：48 hours after surgery
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The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. |
48 hours after surgery
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Platelet-to-lymphocyte ratio
大体时间：24 hours after surgery
|
The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. |
24 hours after surgery
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Time to mobilization
大体时间：within 48 hours
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Time after surgery when the patient moves the toe for the first time |
within 48 hours
|
合作者和调查者
调查人员
- 学习椅：Tomasz Kotwicki, Prof dr hab、Poznan University of Medical Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
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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