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Trial record 13 of 133 for:    Complex Regional Pain Syndrome

Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome (ANI-ALGO)

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ClinicalTrials.gov Identifier: NCT02663284
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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).


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Drug: Ropivacaine 0.5% Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)
Study Start Date : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014


Arm Intervention/treatment
Experimental: Perineural block
Perineural block with Ropivacaine 0.5%
Drug: Ropivacaine 0.5%
Ropivacaine is used to performed the perineural block




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663284


Locations
France
Clinique des 2 Caps
Coquelles, France, 62231
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler Hopital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02663284     History of Changes
Other Study ID Numbers: 2011/67
2011-A01676-35 ( Other Identifier: ANSM )
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Anesthetics, Local
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents