Non-invasive Pain Monitoring in Post-operative Patients

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: ANSPEC-PRO

• Registration Number: NCT03832764
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2018-06-26
• Study Completion: 2018-06-26
• Study First Submitted: 2018-09-11
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-05
• Last Update Submitted: 2019-02-05
• Study First Posted: 2019-02-06
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MEDSTORM	ANSPEC-PRO	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.
ANSPEC-PRO	ANSPEC-PRO	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clara Ionescu; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium