Pain, PostoperativeANSPECNCT03832764
Non-invasive Pain Monitoring in Post-operative Patients
An observational study of Pain, Postoperative, run by University Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ANSPEC-PRO
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2018to 26 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients planned for operation, between 18 and 70 years old, not pregnant, not in chronic pain and not taken anticonvulsants or antidepressants.
Who may be able to join
- patients postoperative of a painfull operation
- between 18 and70 years old
Who cannot join
- day surgery patients
- chronic pain patients
- taken medication : anticonvulsants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients
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
- Being tested
- ANSPEC-PRO
- Keywords
- skin impedance, pain monitoring, observational study, PACU/ICU
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANSPEC-PRODevice
Also called MEDSTORM
Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ANSPEC-PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 140 minutes each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 May 2018
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832764
- Sponsor's protocol ID
- 2017/1517
- Acronym
- ANSPEC
- Status last verified
- Feb 2019
- First submitted
- 11 Sep 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients
- ClinicalTrials.gov ID
- NCT03832764
- Acronym / sponsor ID
- ANSPEC / 2017/1517
- Conditions
- Pain, Postoperative
- Keywords
- skin impedance, pain monitoring, observational study, PACU/ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 1 May 2018 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANSPEC-PRO | – | Device: ANSPEC-PROThese 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. |
| MEDSTORM | – | Device: ANSPEC-PROThese 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for operation, between 18 and 70 years old, not pregnant, not in chronic pain and not taken anticonvulsants or antidepressants.
Key inclusion criteria (2 listed)
- patients postoperative of a painfull operation
- between 18 and70 years old
Key exclusion criteria (3 listed)
- day surgery patients
- chronic pain patients
- taken medication : anticonvulsants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANSPEC-PROAlso: MEDSTORMDevice monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU | Device | ANSPEC-PRO, MEDSTORM |
Primary outcome
Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients. (time frame: 140 minutes each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.