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Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome

NCT ID: NCT02663284

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.

The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).

Detailed Description

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Conditions

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Complex Regional Pain Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Perineural block

Perineural block with Ropivacaine 0.5%

Group Type EXPERIMENTAL

Ropivacaine 0.5%

Intervention Type DRUG

Ropivacaine is used to performed the perineural block

Interventions

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Ropivacaine 0.5%

Ropivacaine is used to performed the perineural block

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb

Exclusion Criteria

* contra-indication of a nerve block,
* contra-indication of the use of the pain monitor
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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Marc Fischler

Role: STUDY_CHAIR

Hopital Foch

Locations

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Clinique des 2 Caps

Coquelles, , France

Site Status

Countries

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France

Other Identifiers

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2011-A01676-35

Identifier Type: OTHER

Identifier Source: secondary_id

2011/67

Identifier Type: -

Identifier Source: org_study_id