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

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT02663284
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome	Drug: Ropivacaine 0.5%	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• 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: Apr 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of ANI before the peri-neural block [5 minutes]

   ANI is recorded before each nerve block

2. Evaluation of pain before the peri-neural block [5 minutes]

   Pain score is recorded before each nerve block

Secondary Outcome Measures

1. Evaluation of ANI after the peri-neural block [10 minutes]

   ANI is recorded after each nerve block

2. Evaluation of pain after the peri-neural block [10 minutes]

   Pain score is recorded after each nerve block

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique des 2 Caps	Coquelles		France	62231

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02663284
• Other Study ID Numbers: 2011/67; 2011-A01676-35
• First Posted: Jan 26, 2016
• Last Update Posted: Nov 3, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders; Ropivacaine

Study Results

No Results Posted as of Nov 3, 2016