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Completed

NCT Number: NCT03267979

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

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video-pupillometer

Other

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

Other names: Algiscan

Electrocardiogram

Other

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

Primary outcomes

  1. Correlation between pupillary diameter (PD) and pain assessment

    Time frame: 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 outcomes

  1. Correlation between pupillary diameter (PD) and heart rate

    Time frame: 1 hour post surgery

    Correlation between pupillary diameter (PD) and heart rate in the post-operative period.

    Heart rate will be measured by electrocardiogram.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PREVANS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2017
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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