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

NCT01832844 | Completed

• 1 other identifier: RC13_0096
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sciatica

Keywords

Scan control; Epidural infiltration; visual analogue scale (VAS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Group " with scan prior to infiltration "

ACTIVE COMPARATOR

Procedure: Group " with scan prior to infiltration "

Group " without scan "

PLACEBO COMPARATOR

Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions

Procedure: Group " without scan "

Interventions

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 " with scan prior to infiltration "

Group " without scan " PROCEDURE

Group " without scan "

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Sciatica

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Benoit LE GOFF, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

FR (1)