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Epidrum for Thoracic Epidural Analgesia

NCT ID: NCT01597466

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Epidrum

Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)

Group Type EXPERIMENTAL

Epidural catheter placement

Intervention Type DEVICE

Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)

Loss of resistance technique

Group Type ACTIVE_COMPARATOR

Epidural catheter placement

Intervention Type PROCEDURE

Epidural space is located using loss of resistance technique (saline solution)

Interventions

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Epidural catheter placement

Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)

Intervention Type DEVICE

Epidural catheter placement

Epidural space is located using loss of resistance technique (saline solution)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Marc Fischler, MD

Role: STUDY_CHAIR

Hopital Foch

Locations

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CHU Marseille

Marseille, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00083-40

Identifier Type: OTHER

Identifier Source: secondary_id

2012/01

Identifier Type: -

Identifier Source: org_study_id