Effects of Control Scan for Presumed Difficult Epidural Infiltrations (ECHORACHIS)

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial

Conditions
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Sciatica

Intervention / Treatment
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* Procedure: Group  with scan prior to infiltration 
* Procedure: Group  without scan 


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group  with scan prior to infiltration <br> | Procedure: Group  with scan prior to infiltration <br>* 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<br>|
| Placebo Comparator: Group  without scan <br>Patients will have a dummy lumber spine evaluation in order to put patients in blind conditions | Procedure: Group  without scan <br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale measuring the pain during infiltration | To evaluate if scan prior to epidural infiltration could improve its tolerance | 10min after the infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scan control, Epidural infiltration, visual analogue scale (VAS)