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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01832844
First received: April 4, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Sciatica
Procedure: Group " with scan prior to infiltration "
Procedure: Group " without scan "

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Visual analogue scale measuring the pain during infiltration [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
    To evaluate if scan prior to epidural infiltration could improve its tolerance


Secondary Outcome Measures:
  • Infiltration evaluation: procedure time between skin passage and release of the needle [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
  • Infiltration evaluation: attempts number before correct positioning of needle [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
  • Infiltration evaluation: number of puncture sites [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
  • Infiltration evaluation: number of failures [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
  • Infiltration tolerance : VAS for pain (graduating from 0 to 10) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1 [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
  • Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1 [ Time Frame: 10min after the infiltration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group " with scan prior to infiltration " 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
Placebo Comparator: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
Procedure: Group " without scan "

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01832844

Locations
France
University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Benoit LE GOFF, Doctor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01832844     History of Changes
Other Study ID Numbers: RC13_0096
Study First Received: April 4, 2013
Last Updated: March 21, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Scan control
Epidural infiltration
visual analogue scale (VAS)

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014