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Non-invasive Pain Monitoring in Post-operative Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03832764
Acronym
ANSPEC
Enrollment
26
Registered
2019-02-06
Start date
2018-05-01
Completion date
2018-06-26
Last updated
2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

skin impedance, pain monitoring, observational study, PACU/ICU

Brief summary

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.

Interventions

DEVICEANSPEC-PRO

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

Sponsors

University Hospital, Ghent
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.140 minutes each patientPain 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026