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NCT01597466 Clinical Trial

Epidrum for Thoracic Epidural Analgesia

Pain Clinical Trial

— Epidrum-Tho  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01597466
Other study ID # 2012/01
Secondary ID 2012-A00083-40
Status Completed
Phase N/A
First received May 5, 2012
Last updated November 2, 2016
Start date April 2013
Est. completion date June 2015

Study information
Verified date November 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
France CHU Marseille Marseille
France Hopital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ease to identify the epidural space Number of cases having required more than 2 punctures and number of failures of the technique 30 minutes No
Secondary Duration of epidural procedure 30 minutes No
Secondary Number of cutaneous punctures 30 minutes No
Secondary Number of needle redirections 30 minutes No
Secondary Ease of epidural catheter insertion 30 minutes No
Secondary Number of inadequate postoperative analgesia asymmetric, incomplete or failed analgesia one day after anesthesia No
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