Evaluation of the Physiodoloris Pain Monitor in Patients... | NCT02663284

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

NCT02663284

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Nov 3, 2016Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Complex Regional Pain Syndrome

Interventions

Ropivacaine 0.5%

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A01676-35	Other Identifier	ANSM

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Sep 29, 2015

First Submission Date that Met QC Criteria

Jan 21, 2016

First Posted Date

Jan 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2016

Last Update Posted Date

Nov 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perineural block	Experimental	Perineural block with Ropivacaine 0.5%	Drug: Ropivacaine 0.5%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine 0.5%	Drug	Ropivacaine is used to performed the perineural block	Perineural block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of ANI before the peri-neural block	ANI is recorded before each nerve block	5 minutes
Evaluation of pain before the peri-neural block	Pain score is recorded before each nerve block	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of ANI after the peri-neural block	ANI is recorded after each nerve block	10 minutes
Evaluation of pain after the peri-neural block	Pain score is recorded after each nerve block

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler	Hopital Foch	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique des 2 Caps		Coquelles		62231	France

Condition Browse Module

MeSH Terms

ID	Term
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided