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OpenTrials
Completed

NCT Number: NCT03832764

Non-invasive Pain Monitoring in Post-operative Patients

During the current pain monitoring system the patient is awake and he/she is asked to give a numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop later a method/algorithm for automatic evaluation of pain (objective measurement of pain). The measurement is done using standard ECG electrodes placed in the hand palm of the patient. The patient feels nothing during the observations, perhaps irritation of skin may occur as result of long time measurement. As a comparison to the investigators prototype, a commercial device is also used in (randomly selected) patients, i.e. the MedStorm device.

The study will try to answer the following questions:

* Are the measurements with the ANSPEC-PRO correlated with the NRS values? * What is the (mathematical) relationship between the measured values and the NRS? * Is there difference between the two devices in measuring pain levels? And what is this difference if pain alleviation medication is given to the patient? * A number of 26 patients is envisaged for this study, equally distributed to be evaluated with the two devices.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clara Ionescu

Ghent, Oost-Vlaanderen, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients postoperative of a painfull operation
  • between 18 and70 years old

Exclusion criteria

  • day surgery patients
  • chronic pain patients
  • taken medication : anticonvulsants

Treatment and study plan

ANSPEC-PRO

Device

Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU

Other names: MEDSTORM

Primary outcomes

  1. Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.

    Time frame: 140 minutes each patient

    Pain monitoring of awake patients which are standardly treated for pain using the numerical rating scale. The main outcome is a correlation between ANSPEC-PRO device and the numerical rating scale.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University Hospital, Ghent

Registry information

Official study title

Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients

Acronym: ANSPEC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2019
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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