Clinical Trials/NCT02663284

NCT02663284

Completed

Not Applicable

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

Hopital Foch1 site in 1 country30 target enrollmentApril 2012

ConditionsComplex Regional Pain Syndrome

InterventionsRopivacaine 0.5%

DrugsRopivacaine 0.5%

Overview

Phase: Not Applicable
Intervention: Ropivacaine 0.5%
Conditions: Complex Regional Pain Syndrome
Sponsor: Hopital Foch
Enrollment: 30
Locations: 1
Primary Endpoint: Evaluation of ANI before the peri-neural block
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

March 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Responsible Party

Sponsor

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

Arms & Interventions

Perineural block

Perineural block with Ropivacaine 0.5%

Intervention: Ropivacaine 0.5%

Outcomes

Primary Outcomes

Evaluation of ANI before the peri-neural block

Time Frame: 5 minutes

ANI is recorded before each nerve block

Evaluation of pain before the peri-neural block

Time Frame: 5 minutes

Pain score is recorded before each nerve block

Secondary Outcomes

Evaluation of ANI after the peri-neural block(10 minutes)
Evaluation of pain after the peri-neural block(10 minutes)

Study Sites (1)

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