Back to resultsEvaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome (ANI-ALGO)
Primary Purpose
Complex Regional Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ropivacaine 0.5%
Sponsored by
About this trial
This is an interventional diagnostic trial for Complex Regional Pain Syndrome
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
Sites / Locations
- Clinique des 2 Caps
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perineural block
Arm Description
Perineural block with Ropivacaine 0.5%
Outcomes
Primary Outcome Measures
Evaluation of ANI before the peri-neural block
ANI is recorded before each nerve block
Evaluation of pain before the peri-neural block
Pain score is recorded before each nerve block
Secondary Outcome Measures
Evaluation of ANI after the peri-neural block
ANI is recorded after each nerve block
Evaluation of pain after the peri-neural block
Pain score is recorded after each nerve block
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02663284
Brief Title
Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineural block
Arm Type
Experimental
Arm Description
Perineural block with Ropivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5%
Intervention Description
Ropivacaine is used to performed the perineural block
Primary Outcome Measure Information:
Title
Evaluation of ANI before the peri-neural block
Description
ANI is recorded before each nerve block
Time Frame
5 minutes
Title
Evaluation of pain before the peri-neural block
Description
Pain score is recorded before each nerve block
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Evaluation of ANI after the peri-neural block
Description
ANI is recorded after each nerve block
Time Frame
10 minutes
Title
Evaluation of pain after the peri-neural block
Description
Pain score is recorded after each nerve block
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fischler
Organizational Affiliation
Hopital Foch
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique des 2 Caps
City
Coquelles
ZIP/Postal Code
62231
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome
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