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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Nantes, France, 44000
- University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group " with scan prior to infiltration "
|
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
|
|
Comparateur placebo: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual analogue scale measuring the pain during infiltration
Délai: 10min after the infiltration
|
To evaluate if scan prior to epidural infiltration could improve its tolerance
|
10min after the infiltration
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Infiltration evaluation: procedure time between skin passage and release of the needle
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Infiltration evaluation: attempts number before correct positioning of needle
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Infiltration evaluation: number of puncture sites
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Infiltration evaluation: number of failures
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Infiltration tolerance : VAS for pain (graduating from 0 to 10)
Délai: 48 hours
|
48 hours
|
|
Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Délai: 48 hours
|
48 hours
|
|
Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "
Délai: 10min after the infiltration
|
10min after the infiltration
|
|
Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "
Délai: 10min after the infiltration
|
10min after the infiltration
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Benoit LE GOFF, Doctor, Nantes University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC13_0096
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .