Non-invasive Pain Monitoring in Post-operative Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: ANSPEC-PRO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients postoperative of a painfull operation between 18 and70 years old Exclusion Criteria: day surgery patients chronic pain patients taken medication : anticonvulsants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ANSPEC-PRO<br>These patients are selected (after randomized selection) to be monitored non-invasively for pain level via prototype ANSPEC-PRO - correlated to a NRS number given by the awake patient in PACU/ICU. | Device: ANSPEC-PRO<br>* Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU<br>* Other names: MEDSTORM;|
| MEDSTORM<br>These patients are selected (after randomized selection) to be monitored non-invasively for pain level via MEDSTORM - correlated to a NRS number given by the awake patient in PACU/ICU. | Device: ANSPEC-PRO<br>* Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU<br>* Other names: MEDSTORM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients. | 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. | 140 minutes each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACU/ICU, skin impedance, pain monitoring, observational study