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CompletedNCT03280238Updated Sep 13, 2017

Pupil Dilation and Analgesia Nociception Index

An interventional study of Measurement of pupil dilation and analgesia nociception index in Pain, sponsored by Vrije Universiteit Brussel. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Pain

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03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testMeasurement 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

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What researchers measure

Primary outcomes

  1. Pupil dilation in relation to pain

    measurement of pupil dilation

    Time frame: 2sec before until 4sec after each painful stimulus

Secondary outcomes

  1. Analgesia nociception index in relation to pain

    measurement of analgesia nociception index

    Time frame: 30sec before until 60sec after each painful stimulus

06

Study locations

1 site
  • UZ Brussel
    Jette, 1090, Belgium
07

References and documents

Publications

  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available. PubMed 8737210 ↗
  • Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. doi: 10.1017/s0048577299970373. PubMed 10098379 ↗
  • Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6. PubMed 23922336 ↗
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Registry details

Key details

Study ID
NCT03280238
Lead sponsor
Vrije Universiteit Brussel
Responsible party
Wendy Van Bogaert (Medical Student, Vrije Universiteit Brussel) — Principal investigator
First posted
Sep 12, 2017
Start date
Mar 1, 2017
Primary completion
May 31, 2017
Completion
May 31, 2017
Last update
Sep 13, 2017

Study contacts

Wendy Van Bogaert, MS
principal investigator · Vrije Universiteit Brussel
Reginald Deschepper, PhD
study chair · Vrije Universiteit Brussel

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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