NCT02663284CompletedNot Applicable
Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Evaluation of ANI before the peri-neural block
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Perineural block with Ropivacaine 0.5%
Intervention: Ropivacaine 0.5% (Drug)
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)
Investigators
Study Sites (1)
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