Epidrum for Thoracic Epidural Analgesia (Epidrum-Tho)

November 2, 2016 updated by: Hopital Foch

A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study

The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13915
        • CHU Marseille
      • Suresnes, France, 92151
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Elective major thoracic surgery requiring thoracic epidural analgesia

Exclusion Criteria:

  • Contraindication to epidural anesthesia
  • Marked spinal deformities or a history of spinal instrumentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidrum
Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
Device: Epidural catheter placement
Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
Active Comparator: Loss of resistance technique
Procedure: Epidural catheter placement
Epidural space is located using loss of resistance technique (saline solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease to identify the epidural space
Time Frame: 30 minutes
Number of cases having required more than 2 punctures and number of failures of the technique
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of epidural procedure
Time Frame: 30 minutes
30 minutes
Number of cutaneous punctures
Time Frame: 30 minutes
30 minutes
Number of needle redirections
Time Frame: 30 minutes
30 minutes
Ease of epidural catheter insertion
Time Frame: 30 minutes
30 minutes
Number of inadequate postoperative analgesia
Time Frame: one day after anesthesia
asymmetric, incomplete or failed analgesia
one day after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 5, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2012/01
  • 2012-A00083-40 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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