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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Nantes, Francja, 44000
- University Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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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Komparator placebo: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual analogue scale measuring the pain during infiltration
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Infiltration evaluation: procedure time between skin passage and release of the needle
Ramy czasowe: 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
Ramy czasowe: 10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of puncture sites
Ramy czasowe: 10min after the infiltration
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10min after the infiltration
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Infiltration evaluation: number of failures
Ramy czasowe: 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)
Ramy czasowe: 48 hours
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48 hours
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Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Ramy czasowe: 48 hours
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48 hours
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Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Ramy czasowe: 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
Ramy czasowe: 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 "
Ramy czasowe: 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 "
Ramy czasowe: 10min after the infiltration
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10min after the infiltration
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Benoit LE GOFF, Doctor, Nantes University Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RC13_0096
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