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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02663284
Acronym
ANI-ALGO
Enrollment
30
Registered
2016-01-26
Start date
2012-04-30
Completion date
2014-03-31
Last updated
2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome

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).

Interventions

Ropivacaine is used to performed the perineural block

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of ANI before the peri-neural block5 minutesANI is recorded before each nerve block
Evaluation of pain before the peri-neural block5 minutesPain score is recorded before each nerve block

Secondary

MeasureTime frameDescription
Evaluation of ANI after the peri-neural block10 minutesANI is recorded after each nerve block
Evaluation of pain after the peri-neural block10 minutesPain score is recorded after each nerve block

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026