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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03267979
Acronym
PREVANS
Enrollment
345
Registered
2017-08-31
Start date
2014-11-02
Completion date
2015-03-31
Last updated
2017-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

pain assessment, pupillary diameter, variation coefficient of pupillary diameter, pain self assessment, video-pupillometer, electrocardiogram, analgesic treatment

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.

Interventions

OTHERVideo-pupillometer

Video-pupillometer will be performed. In this study data will be collected and analyzed.

OTHERElectrocardiogram

Electrocardiogram will be performed. In this study data will be collected and analyzed.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between pupillary diameter (PD) and pain assessment1 hour post surgeryCorrelation 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

MeasureTime frameDescription
Correlation between pupillary diameter (PD) and heart rate1 hour post surgeryCorrelation between pupillary diameter (PD) and heart rate in the post-operative period. Heart rate will be measured by electrocardiogram.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026