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CompletedNCT03267979PREVANSUpdated Aug 31, 2017

Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study

An interventional study of Video-pupillometer and Electrocardiogram in Anesthesia, General, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-31.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
345
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. But, cooperation of the patient is limited by cultural differences, language barriers or residual effect of products used while general anesthesia.

A lot of study were conducted to demonstrate and to quantify the pain after an operation. The aim will be dose analgesic treatment better without cooperation of the patient.

This sudy concerns patients on the post anesthesia care units one hour after their arrival. They will have electrocardiogram and video-pupillometer.

Read the detailed description

Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too, Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to demonstrate a correlation between the three parameters.

02

Conditions studied

  • Anesthesia, General

Keywords

  • pain assessment
  • pupillary diameter
  • variation coefficient of pupillary diameter
  • pain self assessment
  • video-pupillometer
  • electrocardiogram
  • analgesic treatment
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Major patients
  • Patients fluent in French
  • Patient admitted on the post anesthesia care units

Exclusion criteria

Exclusion criteria:

  • Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
  • Emergency operation
  • Heart rhythm disorders
  • Pacemaker
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
345 participants (actual)

Study arms

  • Other
    Patients have a surgical operation

    Patients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer.

    Other: Video-pupillometer · Other: Electrocardiogram

Interventions

  • OtherVideo-pupillometer

    Video-pupillometer will be performed. In this study data will be collected and analyzed.

    Also known as: Algiscan

  • OtherElectrocardiogram

    Electrocardiogram will be performed. In this study data will be collected and analyzed.

05

What researchers measure

Primary outcomes

  1. Correlation between pupillary diameter (PD) and pain assessment

    Correlation between pupillary diameter (PD) and pain in the post-operative period. PD will be measured by video-pupillometer. Pain will be measured by Visual Analog Scale (VAS).

    Time frame: 1 hour post surgery

Secondary outcomes

  1. Correlation between pupillary diameter (PD) and heart rate

    Correlation between pupillary diameter (PD) and heart rate in the post-operative period. Heart rate will be measured by electrocardiogram.

    Time frame: 1 hour post surgery

06

Study locations

1 site
  • CHU de Saint-Etienne
    Saint-Etienne, 42100, France
07

References and documents

Publications

  • Charier D, Vogler MC, Zantour D, Pichot V, Martins-Baltar A, Courbon M, Roche F, Vassal F, Molliex S. Assessing pain in the postoperative period: Analgesia Nociception IndexTMversus pupillometry. Br J Anaesth. 2019 Aug;123(2):e322-e327. doi: 10.1016/j.bja.2018.09.031. Epub 2019 Jan 26. PubMed 30915996 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03267979
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Nov 2, 2014
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015
Last update
Aug 31, 2017

Study contacts

David CHARIER, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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