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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Anesthesia, General

Intervention / Treatment
-----------------
* Other: Video-pupillometer
* Other: Electrocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients have a surgical operation<br>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<br>* Video-pupillometer will be performed. In this study data will be collected and analyzed.<br>* Other names: Algiscan;Other: Electrocardiogram<br>* Electrocardiogram will be performed. In this study data will be collected and analyzed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 hour post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain assessment, pupillary diameter, variation coefficient of pupillary diameter, pain self assessment, video-pupillometer, electrocardiogram, analgesic treatment