Epidrum for Thoracic Epidural Analgesia

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Epidural catheter placement

• Registration Number: NCT01597466
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Study Start: 2013-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Elective major thoracic surgery requiring thoracic epidural analgesia

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidrum	Epidural catheter placement	Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
Loss of resistance technique	Epidural catheter placement	-

Primary Outcome Measures

Name	Time	Method
Ease to identify the epidural space	30 minutes	Number of cases having required more than 2 punctures and number of failures of the technique

Secondary Outcome Measures

Name	Time	Method
Number of cutaneous punctures	30 minutes
Ease of epidural catheter insertion	30 minutes
Number of inadequate postoperative analgesia	one day after anesthesia	asymmetric, incomplete or failed analgesia
Duration of epidural procedure	30 minutes
Number of needle redirections	30 minutes

Trial Locations

Locations (2)

CHU Marseille; 🇫🇷 Marseille, France

Hopital Foch; 🇫🇷 Suresnes, France