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Epidrum for Thoracic Epidural Analgesia (Epidrum-Tho)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01597466
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pain Device: Epidural catheter placement Procedure: Epidural catheter placement

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study
Study Start Date : April 2013
Primary Completion Date : June 2015
Study Completion Date : June 2015
Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration of epidural procedure [ Time Frame: 30 minutes ]
  2. Number of cutaneous punctures [ Time Frame: 30 minutes ]
  3. Number of needle redirections [ Time Frame: 30 minutes ]
  4. Ease of epidural catheter insertion [ Time Frame: 30 minutes ]
  5. Number of inadequate postoperative analgesia [ Time Frame: one day after anesthesia ]
    asymmetric, incomplete or failed analgesia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597466


Locations
France
CHU Marseille
Marseille, France, 13915
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hopital Foch
Study Chair: Marc Fischler, MD Hopital Foch
More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01597466     History of Changes
Other Study ID Numbers: 2012/01
2012-A00083-40 ( Other Identifier: ANSM )
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016