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

NCT ID: NCT03267979

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-02

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Anesthesia, General

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients have a surgical operation

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

Group Type OTHER

Video-pupillometer

Intervention Type OTHER

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

Electrocardiogram

Intervention Type OTHER

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

Interventions

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Video-pupillometer

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

Intervention Type OTHER

Electrocardiogram

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

Intervention Type OTHER

Other Intervention Names

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Algiscan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David CHARIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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Charier D, Vogler MC, Zantour D, Pichot V, Martins-Baltar A, Courbon M, Roche F, Vassal F, Molliex S. Assessing pain in the postoperative period: Analgesia Nociception IndexTMversus pupillometry. Br J Anaesth. 2019 Aug;123(2):e322-e327. doi: 10.1016/j.bja.2018.09.031. Epub 2019 Jan 26.

Reference Type DERIVED
PMID: 30915996 (View on PubMed)

Other Identifiers

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CNIL

Identifier Type: OTHER

Identifier Source: secondary_id

IRBN402014/CHUSTE

Identifier Type: -

Identifier Source: org_study_id