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Completed

NCT Number: NCT01832844

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group " with scan prior to infiltration "

Procedure

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

Group " without scan "

Procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. Infiltration evaluation: procedure time between skin passage and release of the needle

    Time frame: 10min after the infiltration

  2. Infiltration evaluation: attempts number before correct positioning of needle

    Time frame: 10min after the infiltration

  3. Infiltration evaluation: number of puncture sites

    Time frame: 10min after the infiltration

  4. Infiltration evaluation: number of failures

    Time frame: 10min after the infiltration

  5. Infiltration tolerance : VAS for pain (graduating from 0 to 10)

    Time frame: 48 hours

  6. Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)

    Time frame: 48 hours

  7. Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1

    Time frame: 10min after the infiltration

  8. Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1

    Time frame: 10min after the infiltration

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial

Acronym: ECHORACHIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 16, 2013
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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