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Epidrum for Thoracic Epidural Analgesia (Epidrum-Tho)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01597466
First received: May 5, 2012
Last updated: November 2, 2016
Last verified: November 2016

May 5, 2012
November 2, 2016
April 2013
June 2015   (final data collection date for primary outcome measure)
Ease to identify the epidural space [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Number of cases having required more than 2 punctures and number of failures of the technique
Same as current
Complete list of historical versions of study NCT01597466 on ClinicalTrials.gov Archive Site
  • Duration of epidural procedure [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Number of cutaneous punctures [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Number of needle redirections [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Ease of epidural catheter insertion [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Number of inadequate postoperative analgesia [ Time Frame: one day after anesthesia ] [ Designated as safety issue: No ]
    asymmetric, incomplete or failed analgesia
Same as current
Not Provided
Not Provided
 
Epidrum for Thoracic Epidural Analgesia
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pain
  • Device: Epidural catheter placement
    Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
  • Procedure: Epidural catheter placement
    Epidural space is located using loss of resistance technique (saline solution)
  • Experimental: Epidrum
    Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
    Intervention: Device: Epidural catheter placement
  • Active Comparator: Loss of resistance technique
    Intervention: Procedure: Epidural catheter placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01597466
2012/01, 2012-A00083-40
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Principal Investigator: Morgan Le Guen, MD Hopital Foch
Study Chair: Marc Fischler, MD Hopital Foch
Hopital Foch
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP