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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Nantes, França, 44000
- University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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Comparador de Placebo: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual analogue scale measuring the pain during infiltration
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Infiltration evaluation: procedure time between skin passage and release of the needle
Prazo: 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
Prazo: 10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of puncture sites
Prazo: 10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of failures
Prazo: 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)
Prazo: 48 hours
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48 hours
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Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Prazo: 48 hours
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48 hours
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Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Prazo: 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
Prazo: 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 "
Prazo: 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 "
Prazo: 10min after the infiltration
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10min after the infiltration
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Benoît LE GOFF, Doctor, Nantes university hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RC13_0096
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