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

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Other: Video-pupillometer; Other: Electrocardiogram

• Registration Number: NCT03267979
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2014-11-02
• Primary Completion: 2015-03-31
• Study Completion: 2015-03-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-29
• Last Update Submitted: 2017-08-29
• Study First Posted: 2017-08-31
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Correlation between pupillary diameter (PD) and pain assessment	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).

Secondary Outcome Measures

Name	Time	Method
Correlation between pupillary diameter (PD) and heart rate	1 hour post surgery	Correlation between pupillary diameter (PD) and heart rate in the post-operative period.; Heart rate will be measured by electrocardiogram.

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France