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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Anesthesia, General

Treatments: Other: Video-pupillometer; Other: Electrocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT03267979

CNIL (Other Identifier)

IRBN402014/CHUSTE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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345 participants in 1 patient group

Patients have a surgical operation

Other group

Description:

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

Treatment:

Other: Video-pupillometer

Other: Electrocardiogram