Non-invasive Pain Monitoring in Post-operative Patients

NCT ID: NCT03832764

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-06-26

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.

Conditions

Pain, Postoperative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ANSPEC-PRO

Intervention Type: DEVICE

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

MEDSTORM

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

Intervention Type: DEVICE

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

Interventions

ANSPEC-PRO

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

Intervention Type: DEVICE

Other Intervention Names

MEDSTORM

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clara Ionescu

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

2017/1517

Identifier Type: -

Identifier Source: org_study_id