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Completed

NCT Number: NCT02663284

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

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).

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Key information

Conditions

Complex Regional Pain Syndrome Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique des 2 Caps

Coquelles, 62231, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.5%

Drug

Ropivacaine is used to performed the perineural block

Primary outcomes

  1. Evaluation of ANI before the peri-neural block

    Time frame: 5 minutes

    ANI is recorded before each nerve block

  2. Evaluation of pain before the peri-neural block

    Time frame: 5 minutes

    Pain score is recorded before each nerve block

Secondary outcomes

  1. Evaluation of ANI after the peri-neural block

    Time frame: 10 minutes

    ANI is recorded after each nerve block

  2. Evaluation of pain after the peri-neural block

    Time frame: 10 minutes

    Pain score is recorded after each nerve block

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: ANI-ALGO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2016
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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