Non-invasive Pain Monitoring in Post-operative Patients

Pain, Postoperative Clinical Trial

— ANSPEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832764
• Other study ID #: 2017/1517
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: June 26, 2018

Study information

• Verified date: February 2019
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients postoperative of a painfull operation

• between 18 and70 years old

Exclusion Criteria:

• day surgery patients

• chronic pain patients

• taken medication : anticonvulsants

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• ANSPEC-PRO
Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU

Locations

Country	Name	City	State
Belgium	Clara Ionescu	Ghent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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