Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block
Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures
研究概览
地位
详细说明
Fracture femur is a common injury which is associated with excruciating pain . This pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. Pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. These problems can be prevented by successful management of postoperative pain.
In patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. Paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia.
Currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. The use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding adjuvants is another potential alternative.
Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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DK
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Mansoura、DK、埃及、050
- Mansoura University
-
-
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:
- American Society of Anesthesiologists physical class I or II
Exclusion Criteria:
- Patient refusal.
- Severe or uncompensated cardiovascular disease.
- Severe or uncompensated renal disease.
- Severe or uncompensated hepatic disease.
- Severe or uncompensated endocrinal disease.
- Pregnancy.
- Postpartum ladies.
- Lactating females.
- Allergy to any of the study medications .
- Coagulation disorders.
- Infection at the site of needle insertion
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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 |
|---|---|
|
安慰剂比较:Bupivacaine group
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
|
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
|
|
有源比较器:Mixture of bupivacaine and dexmedetomidine group
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine
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Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine
|
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 |
|---|---|---|
|
Scale for radiological spread of the injectate
大体时间:for 20 min after performing the blockade
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It will be assessed using the following scale -2; spread for two vertebral levels below the site of injection, -1; spread for one vertebral level below the site of injection, 0; stays at the level of injection, +2; spread for two vertebral levels above the site of injection, +1; spread for one vertebral level above the site of injection
|
for 20 min after performing the blockade
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain scores
大体时间:For 48 hours after surgery
|
The severity of pain will be assessed using a visual analog scale (VAS)
|
For 48 hours after surgery
|
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Duration of postoperative analgesia
大体时间:for 24 hours after surgery
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The period from completion of the block to time of administration of the first request of rescue analgesic for postoperative pain will be recorded
|
for 24 hours after surgery
|
|
Postoperative analgesic consumption
大体时间:for 48 hours after surgery
|
Total postoperative analgesic consumption
|
for 48 hours after surgery
|
合作者和调查者
调查人员
- 首席研究员:Reem A El sharkawy, MD、Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
- 研究主任:Mohamed Y Makharita, MD、Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
- 学习椅:Nabil Abd-El Raouf, MD、Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
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 (估计)
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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