Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
PREVANS
2 other identifiers
interventional
345
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2015
CompletedFirst Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedAugust 31, 2017
August 1, 2017
5 months
August 25, 2017
August 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Correlation between pupillary diameter (PD) and heart rate
1 hour post surgery
Study Arms (1)
Patients have a surgical operation
OTHERPatients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer.
Interventions
Video-pupillometer will be performed. In this study data will be collected and analyzed.
Electrocardiogram will be performed. In this study data will be collected and analyzed.
Eligibility Criteria
You may qualify if:
- Major patients
- Patients fluent in French
- Patient admitted on the post anesthesia care units
You may not qualify if:
- Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
- Emergency operation
- Heart rhythm disorders
- Pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Saint-Etienne
Saint-Etienne, 42100, France
Related Publications (1)
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.
PMID: 30915996DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
David CHARIER, MD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2017
First Posted
August 31, 2017
Study Start
November 2, 2014
Primary Completion
March 31, 2015
Study Completion
March 31, 2015
Last Updated
August 31, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share