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Pupil Dilation and Analgesia Nociception Index

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ClinicalTrials.gov Identifier: NCT03280238
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Wendy Van Bogaert, 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.

Condition or disease Intervention/treatment Phase
Pain Diagnostic Test: Measurement of pupil dilation and analgesia nociception index Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

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Arm Intervention/treatment
Experimental: 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)
Diagnostic Test: 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




Primary Outcome Measures :
  1. Pupil dilation in relation to pain [ Time Frame: 2sec before until 4sec after each painful stimulus ]
    measurement of pupil dilation


Secondary Outcome Measures :
  1. Analgesia nociception index in relation to pain [ Time Frame: 30sec before until 60sec after each painful stimulus ]
    measurement of analgesia nociception index



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280238


Locations
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Belgium
UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
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Principal Investigator: Wendy Van Bogaert, MS Vrije Universiteit Brussel
Study Chair: Reginald Deschepper, PhD Vrije Universiteit Brussel