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

Sciatica Clinical Trial

— ECHORACHIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832844
• Other study ID #: RC13_0096
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: March 21, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Sciatica

Intervention

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
• Group " without scan "

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale measuring the pain during infiltration	To evaluate if scan prior to epidural infiltration could improve its tolerance	10min after the infiltration	No
Secondary	Infiltration evaluation: procedure time between skin passage and release of the needle		10min after the infiltration	No
Secondary	Infiltration evaluation: attempts number before correct positioning of needle		10min after the infiltration	No
Secondary	Infiltration evaluation: number of puncture sites		10min after the infiltration	No
Secondary	Infiltration evaluation: number of failures		10min after the infiltration	No
Secondary	Infiltration tolerance : VAS for pain (graduating from 0 to 10)		48 hours	Yes
Secondary	Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)		48 hours	Yes
Secondary	Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1		10min after the infiltration	No
Secondary	Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1		10min after the infiltration	No
Secondary	Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "		10min after the infiltration	No
Secondary	Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "		10min after the infiltration	No