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

August 29, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42100
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Video-pupillometer will be performed. In this study data will be collected and analyzed.
Other Names:
  • Algiscan
Other: Electrocardiogram
Electrocardiogram will be performed. In this study data will be collected and analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between pupillary diameter (PD) and pain assessment
Time Frame: 1 hour post surgery

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).
1 hour post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between pupillary diameter (PD) and heart rate
Time Frame: 1 hour post surgery

Correlation between pupillary diameter (PD) and heart rate in the post-operative period.

Heart rate will be measured by electrocardiogram.
1 hour post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2014

Primary Completion (Actual)

March 31, 2015

Study Completion (Actual)

March 31, 2015

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN402014/CHUSTE
  • CNIL (Other Identifier: 1800890)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia, General

Clinical Trials on Video-pupillometer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe