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NCT02663284 Clinical Trial

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

Complex Regional Pain Syndrome Clinical Trial

— ANI-ALGO  

Official title:
Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02663284
Other study ID # 2011/67
Secondary ID 2011-A01676-35
Status Completed
Phase N/A
First received September 29, 2015
Last updated November 2, 2016
Start date April 2012
Est. completion date March 2014

Study information
Verified date November 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine 0.5%
Ropivacaine is used to performed the perineural block

Locations
Country Name City State
France Clinique des 2 Caps Coquelles

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of ANI before the peri-neural block ANI is recorded before each nerve block 5 minutes No
Primary Evaluation of pain before the peri-neural block Pain score is recorded before each nerve block 5 minutes No
Secondary Evaluation of ANI after the peri-neural block ANI is recorded after each nerve block 10 minutes No
Secondary Evaluation of pain after the peri-neural block Pain score is recorded after each nerve block 10 minutes No
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