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

Anesthesia, General Clinical Trial

— PREVANS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267979
• Other study ID #: IRBN402014/CHUSTE
• Secondary ID: CNIL
• Status: Completed
• Phase: N/A
• First received: August 25, 2017
• Last updated: August 29, 2017
• Start date: November 2, 2014
• Est. completion date: March 31, 2015

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: March 31, 2015
• Est. primary completion date: March 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Other:
• Video-pupillometer
Video-pupillometer will be performed. In this study data will be collected and analyzed.
• Electrocardiogram
Electrocardiogram will be performed. In this study data will be collected and analyzed.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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