Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: September 22, 2016
Last verified: September 2016
  Purpose
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 Intervention
Pain
Device: Epidural catheter placement
Procedure: Epidural catheter placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 46
Study Start Date: April 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: May 5, 2012
Last Updated: September 22, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 28, 2016