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

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ClinicalTrials.gov Identifier: NCT01832844
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

April 4, 2013
April 16, 2013
March 24, 2014
April 2013
January 2014   (Final data collection date for primary outcome measure)
Visual analogue scale measuring the pain during infiltration [ Time Frame: 10min after the infiltration ]
To evaluate if scan prior to epidural infiltration could improve its tolerance
Same as current
Complete list of historical versions of study NCT01832844 on ClinicalTrials.gov Archive Site
  • Infiltration evaluation: procedure time between skin passage and release of the needle [ Time Frame: 10min after the infiltration ]
  • Infiltration evaluation: attempts number before correct positioning of needle [ Time Frame: 10min after the infiltration ]
  • Infiltration evaluation: number of puncture sites [ Time Frame: 10min after the infiltration ]
  • Infiltration evaluation: number of failures [ Time Frame: 10min after the infiltration ]
  • Infiltration tolerance : VAS for pain (graduating from 0 to 10) [ Time Frame: 48 hours ]
  • Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other) [ Time Frame: 48 hours ]
  • Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1 [ Time Frame: 10min after the infiltration ]
  • Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1 [ Time Frame: 10min after the infiltration ]
  • Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good " [ Time Frame: 10min after the infiltration ]
  • Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good " [ Time Frame: 10min after the infiltration ]
Same as current
Not Provided
Not Provided
 
Effects of Control Scan for Presumed Difficult Epidural Infiltrations (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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Sciatica
  • Procedure: 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
  • Procedure: Group " without scan "
  • Active Comparator: Group " with scan prior to infiltration "
    Intervention: Procedure: Group " with scan prior to infiltration "
  • Placebo Comparator: Group " without scan "
    Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
    Intervention: Procedure: Group " without scan "
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Same as current
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01832844
RC13_0096
No
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Benoit LE GOFF, Doctor Nantes University Hospital
Nantes University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP