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

21. mars 2014 oppdatert av: Nantes University Hospital

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Nantes, Frankrike, 44000
        • University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Group " with scan prior to infiltration "
Fremgangsmåte: 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
Placebo komparator: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
Fremgangsmåte: Group " without scan "

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual analogue scale measuring the pain during infiltration
Tidsramme: 10min after the infiltration
To evaluate if scan prior to epidural infiltration could improve its tolerance
10min after the infiltration

Sekundære resultatmål

Resultatmål
Tidsramme
Infiltration evaluation: procedure time between skin passage and release of the needle
Tidsramme: 10min after the infiltration
10min after the infiltration
Infiltration evaluation: attempts number before correct positioning of needle
Tidsramme: 10min after the infiltration
10min after the infiltration
Infiltration evaluation: number of puncture sites
Tidsramme: 10min after the infiltration
10min after the infiltration
Infiltration evaluation: number of failures
Tidsramme: 10min after the infiltration
10min after the infiltration
Infiltration tolerance : VAS for pain (graduating from 0 to 10)
Tidsramme: 48 hours
48 hours
Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
Tidsramme: 48 hours
48 hours
Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
Tidsramme: 10min after the infiltration
10min after the infiltration
Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1
Tidsramme: 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 "
Tidsramme: 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 "
Tidsramme: 10min after the infiltration
10min after the infiltration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nantes University Hospital

Etterforskere

  • Hovedetterforsker: Benoit LE GOFF, Doctor, Nantes University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2013

Primær fullføring (Faktiske)

1. januar 2014

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

4. april 2013

Først innsendt som oppfylte QC-kriteriene

12. april 2013

Først lagt ut (Anslag)

16. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. mars 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mars 2014

Sist bekreftet

1. mars 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RC13_0096

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