Non-invasive Pain Monitoring in Post-operative Patients

NCT03832764 | Completed

• 1 other identifier: 2017/1517
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Device: ANSPEC-PRO

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.

Device: ANSPEC-PRO

Interventions

ANSPEC-PRO DEVICE

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

Also known as: MEDSTORM

ANSPEC-PRO; MEDSTORM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planned for operation, between 18 and 70 years old, not pregnant, not in chronic pain and not taken anticonvulsants or antidepressants.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Clara Ionescu

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: February 6, 2019
• Study Start: May 1, 2018
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

BE (1)