Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
研究概览
详细说明
This study will be: controlled, prospective, randomized and double blind.
Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention:
(Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml.
(Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.
Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days .
It will also evaluate analgesic consumption, complications and labor return
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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Capital Federal
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Ciudad Autonoma de Buenos Aires、Capital Federal、阿根廷、C1199ABB
- Hospital Italiano de Buenos Aires, Peron 4190
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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:
- Patients older than 18 years.
- Unilateral inguinal hernioplasty.
- That the surgery is performed in the Ambulatory Surgery Unit (UCA).
Exclusion Criteria:
- Recurrent hernia.
- allergies, ongoing infections, diabetes.
- Background of rejection of prosthetic material (mesh).
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 |
|---|---|
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实验性的：Bupivacaine-Dexamethasone
bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml
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Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
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有源比较器：Bupivacaine- physiological solution
bupivacaine 1,5 mg/kg + physiological solution
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Bupivacaine 1,5 mg/kg- physiological solution
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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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pain postoperative
大体时间：3 month
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It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
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3 month
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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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take analgesic
大体时间：1 month
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Medication journal completed by patient
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1 month
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合作者和调查者
调查人员
- 首席研究员：Sebastian SR Roche, doctor、Hospital Italiano de Buenos Aires
研究记录日期
研究主要日期
学习开始
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
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.
Bupivacaine-Dexamethasone的临床试验
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Pakistan Navy Station Shifa Hospital完全的
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Mahmoud Rafaat Mohamed招聘中
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Medical University of Lodz招聘中
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Federal University of São PauloFaculdade de Ciências Médicas da Santa Casa de São Paulo未知