Pupil Dilation and Analgesia Nociception Index

Not Applicable

Completed

• Conditions: Pain
• Interventions: Diagnostic Test: Measurement of pupil dilation and analgesia nociception index

• Registration Number: NCT03280238
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2017-09
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experiment	Measurement of pupil dilation and analgesia nociception index	* 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)

Primary Outcome Measures

Name	Time	Method
Pupil dilation in relation to pain	2sec before until 4sec after each painful stimulus	measurement of pupil dilation

Secondary Outcome Measures

Name	Time	Method
Analgesia nociception index in relation to pain	30sec before until 60sec after each painful stimulus	measurement of analgesia nociception index

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium