Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 345
- Locations
- 1
- Primary Endpoint
- Correlation between pupillary diameter (PD) and pain assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Video-pupillometer (Other)
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.
Intervention: Electrocardiogram (Other)
Outcomes
Primary Outcomes
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
- Correlation between pupillary diameter (PD) and heart rate(1 hour post surgery)