Effects of Control Scan for Presumed Difficult Epidural Infiltrations (ECHORACHIS) (ECHORACHIS)
Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial
The aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica.
These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors.
Epidural infiltration in young patients, with an easy anatomical identification, causes generally no technical difficulties, therefore this protocol will only include patients presumed to have a difficult infiltration, that means those aged more than 60, and/or with BMI > 30 and/or suffering from scoliosis.
This study concerns patients who are hospitalized in Rheumatology Department (Hospital of Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.
Patient will be randomized at Day 0, before infiltration. This latter will be performed in accordance to current practice.
Tolerance data (pain and satisfaction) will be collected just after the infiltration and eventual complications will be reported within 48 hours after infiltration.
Following treatment of lombosciatic will be realized through hospitalization, as usual.
Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the musculoskeletal clinical exam and it has already changed our rheumatology practices. The investigators hope at the end of this study, that results would confirm that scan can be a help in practice to perform epidural infiltrations.
研究概览
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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Nantes、法国、44000
- University Hospital
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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:
- Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment.
- Inclusion of patients older than 60 years and / or BMI superior to 30 and / or scoliosis
Exclusion Criteria:
- Refusal to participate
- History of spinal surgery
- Anticoagulant or antiplatelet
- History of spinal malformations type spina bifida
- pregnancy
- Age<18
- Patients under guardianship
- Patients participating to another clinical trial (except non interventional trials)
- Patients unable to achieve the protocol, in the judgment of the investigator
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Group " with scan prior to infiltration "
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Scan will be conducted by the operator performing the gesture.
He will examine the lumbar spine from L3 to S1, in longitudinal and cross sections and determine the best surgical approach.
This will be defined by the largest interspinous space or better visibility of the epidural space.
The depth of the epidural space will be noted.
The selected stage will be marked with a skin pen to facilitate its location thereafter
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安慰剂比较:Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
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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 |
---|---|---|
Visual analogue scale measuring the pain during infiltration
大体时间:10min after the infiltration
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To evaluate if scan prior to epidural infiltration could improve its tolerance
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10min after the infiltration
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次要结果测量
结果测量 |
大体时间 |
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Infiltration evaluation: procedure time between skin passage and release of the needle
大体时间:10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: attempts number before correct positioning of needle
大体时间:10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of puncture sites
大体时间:10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of failures
大体时间:10min after the infiltration
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10min after the infiltration
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Infiltration tolerance : VAS for pain (graduating from 0 to 10)
大体时间:48 hours
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48 hours
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Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
大体时间:48 hours
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48 hours
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Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
大体时间:10min after the infiltration
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10min after the infiltration
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Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1
大体时间:10min after the infiltration
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10min after the infiltration
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Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "
大体时间:10min after the infiltration
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10min after the infiltration
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Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "
大体时间:10min after the infiltration
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10min after the infiltration
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合作者和调查者
调查人员
- 首席研究员:Benoit LE GOFF, Doctor、Nantes University Hospital
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 (估计)
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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