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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nantes, Francia, 44000
- University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Comparatore placebo: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Visual analogue scale measuring the pain during infiltration
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Infiltration evaluation: procedure time between skin passage and release of the needle
Lasso di tempo: 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
Lasso di tempo: 10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of puncture sites
Lasso di tempo: 10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of failures
Lasso di tempo: 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)
Lasso di tempo: 48 hours
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48 hours
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Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Lasso di tempo: 48 hours
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48 hours
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Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Lasso di tempo: 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
Lasso di tempo: 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 "
Lasso di tempo: 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 "
Lasso di tempo: 10min after the infiltration
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10min after the infiltration
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Benoit LE GOFF, Doctor, Nantes University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RC13_0096
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