Overview

This trial is active, not recruiting.

Conditions pain, cancer
Treatment non invasive monitoring device (ani)
Sponsor Hopital Foch
Start date August 2012
End date August 2016
Trial size 80 participants
Trial identifier NCT02902627, 2011-A01559-32, 2011/64

Summary

l'ANI (Analgesia Nociception Index

The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
non invasive monitoring device (ani)
Pain measure by ANI monitor and with visual analogical scale

Primary Outcomes

Measure
Comparison of the ANI parameter with the VAS
time frame: 4 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - more than 18 years, -no legal protection, - - life expectancy is considered over 3-months - not receiving of béta-blocking, - Having a rhythm sinusal without extrasystole - benefiting from a coverage by a social security system Exclusion Criteria: - Pace-Maker - Diabetes mellitus

Additional Information

Official title Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study
Principal investigator Marc Fischler
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hopital Foch.