Pupil Dilation and Analgesia Nociception Index

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-05-31

Brief Summary

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Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.

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Detailed Description

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Conditions

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Pain

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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Experiment

* Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode
* Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France)
* Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)

Group Type EXPERIMENTAL

Measurement of pupil dilation and analgesia nociception index

Intervention Type DIAGNOSTIC_TEST

painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured

Interventions

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Measurement of pupil dilation and analgesia nociception index

painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* good health
* no acute or chronic pain conditions
* well rested

Exclusion Criteria

* chronic treatment
* bad health
* daily use of analgetics or other medication
* weekly tobacco use
* weekly use of recreational drugs
* more than 10 alcohol consumptions a week

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes