NCT02663284

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

September 29, 2015

Last Update Submit

November 2, 2016

Conditions

Complex Regional Pain Syndrome

Outcome Measures

Primary Outcomes (2)

  • Evaluation of ANI before the peri-neural block

    ANI is recorded before each nerve block

    5 minutes

  • Evaluation of pain before the peri-neural block

    Pain score is recorded before each nerve block

    5 minutes

Secondary Outcomes (2)

  • Evaluation of ANI after the peri-neural block

    10 minutes

  • Evaluation of pain after the peri-neural block

    10 minutes

Study Arms (1)

Perineural block

EXPERIMENTAL

Perineural block with Ropivacaine 0.5%

Drug: Ropivacaine 0.5%

Interventions

Ropivacaine 0.5%DRUG

Ropivacaine is used to performed the perineural block

Perineural block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb

You may not qualify if:

  • contra-indication of a nerve block,
  • contra-indication of the use of the pain monitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique des 2 Caps

Coquelles, 62231, France

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Marc Fischler

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

January 26, 2016

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(1)