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.

Study Overview

• Status: Completed
• Conditions: Sciatica
• Intervention / Treatment: Procedure: Group " with scan prior to infiltration "; Procedure: Group " without scan "

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 "

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale measuring the pain during infiltration	To evaluate if scan prior to epidural infiltration could improve its tolerance	10min after the infiltration

Secondary Outcome Measures

Outcome Measure	Time Frame
Infiltration evaluation: procedure time between skin passage and release of the needle	10min after the infiltration
Infiltration evaluation: attempts number before correct positioning of needle	10min after the infiltration
Infiltration evaluation: number of puncture sites	10min after the infiltration
Infiltration evaluation: number of failures	10min after the infiltration
Infiltration tolerance : VAS for pain (graduating from 0 to 10)	48 hours
Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)	48 hours
Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1	10min after the infiltration
Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1	10min after the infiltration
Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "	10min after the infiltration
Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "	10min after the infiltration

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Benoit LE GOFF, Doctor, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Scan control; Epidural infiltration; visual analogue scale (VAS)
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica
• Other Study ID Numbers: RC13_0096