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

Not Applicable

Completed

• Conditions: Sciatica
• Interventions: Procedure: Group " without scan "; Procedure: Group " with scan prior to infiltration "

• Registration Number: NCT01832844
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group " without scan "	Group " without scan "	Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
Group " with scan prior to infiltration "	Group " with scan prior to infiltration "	-

Primary Outcome Measures

Name	Time	Method
Visual analogue scale measuring the pain during infiltration	10min after the infiltration	To evaluate if scan prior to epidural infiltration could improve its tolerance

Secondary Outcome Measures

Name	Time	Method
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
Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "	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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France