Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual analogue scale measuring the pain during infiltration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Refusal to participate
- •History of spinal surgery
- •Anticoagulant or antiplatelet
- •History of spinal malformations type spina bifida
- •pregnancy
- •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
研究组 & 干预措施
Group " with scan prior to infiltration "
干预措施: Group " with scan prior to infiltration " (Procedure)
Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
干预措施: Group " without scan " (Procedure)
结局指标
主要结局
Visual analogue scale measuring the pain during infiltration
时间窗: 10min after the infiltration
To evaluate if scan prior to epidural infiltration could improve its tolerance
次要结局
- Infiltration evaluation: procedure time between skin passage and release of the needle(10min after the infiltration)
- Infiltration evaluation: attempts number before correct positioning of needle(10min after the infiltration)
- Infiltration evaluation: number of puncture sites(10min after the infiltration)
- Infiltration evaluation: number of failures(10min after the infiltration)
- Infiltration tolerance : VAS for pain (graduating from 0 to 10)(48 hours)
- Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)(48 hours)
- Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1(10min after the infiltration)
- Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1(10min after the infiltration)
- Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "(10min after the infiltration)
- Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "(10min after the infiltration)