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Pain, Chronic Post-SurgicalPERISCOPEcareNCT05526976

PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

An observational study of Pain, Chronic Post-Surgical, run by University Hospital, Antwerp at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assessment and management for improved wellbeing after elective surgery (PERISCOP³E-Care) Diagnostic assessment tool evaluation and cut-off determination for participation in a transmural perioperative care program Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain, Chronic Post-Surgical
What is being tested?
PERISCOPE-care
How many people
660 participants
Where
2 sitesBelgium
Study dates
22 Dec 2022to 6 Mar 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The first 560 patients who will undergo an elective surgery and have a preop consultation with a pain physician.

Who may be able to join

  • Adult patiënts (≥ 18 year)
  • planned elective surgery @ University Hospital Antwerp

Who cannot join

  • incapacitated
  • cognitive dificit that makes it impossible to complete the questionnaires
  • language barrier

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • University Hospital Antwerp

    Antwerp

  • UZA

    Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Assessment and management for improved wellbeing after elective surgery (PERISCOP³E-Care) Diagnostic assessment tool evaluation and cut-off determination for participation in a transmural perioperative care program

Read the detailed description

Adult patients (≥ 18y) who are planned to undergo an elective surgery at the University Hospital Antwerp, will be invited to participate. After signing the informed consent, they will be asked to complete questionnaires (PERISCOP3E-care; Kalkman \& modified-Althaus, DN4, HADS, Stait-trait, NRS, MPIn EQ-5D-5L) that involve screening of the risk to develop persistend postoperative pain (PPSP).

The questionnaires will be completed via a survey link to the RedCap platform. Invites will be send out via the patient's e-mail.

Demograpic data and relevant medical history, surgery history, concomitant medication will be registered.

one month and three months post surgery the patients will be contacted to identicate if they developed PPSP. They will also be asked to complete quesionnaires (MPI, HADS, Stai-Trait, NRS, MPI, DN4). Based on this info, the cut-off value will be defined for the preoperative questionnaire. Analysis will be done for the sensitivity and specificity of the questionnaires.

Being tested
PERISCOPE-care
Keywords
Persistent postoperative pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PERISCOPE-careOther

    Patients with planned elective surgery will be asked to complete the PERISCOP3E-Care questionnaire (modified-Althaus \& Kalkman, DN4, HADS, Stait-trait, NRS, MPI, EQ-5D-5L) preoperative. One month and three months post op the patients will be contacted to check if they developed persistend postoperative pain and they will also complete questionnaires (DN4, HADS, Stait-trait, NRS, MPI and EQ-5D-5L).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cut-off determination

    Cut-off score determination for Kalkman and modified-Althaus risk for the prevention of persistend pain post op. Determination of inclusion and exclusion in the transmural care path

    Measured: preoperative

Secondary outcomes (8)

  1. Postoperative pain

    Determination with numeric rating schale, NRS (numeric rating scale). Values from 0-10 with 10 being the highest pain you can have.

    Measured: postoperative (day 0 or 1day post surgery)

  2. Persistent postoperative pain

    Determination of persistent postoperative pain via NRS (numeric rating scale). Values from 0-10 with 10 being the highest pain you can have.

    Measured: 1 month and 3months post surgery

  3. The use of opioids

    Need for daily intake of opioids (started postoperative) after surgery

    Measured: 1month and 3months post surgery

  4. The patients well-being

    Evaluation of the well-being measured with EQ-5D-5L questionnaire (5-level EQ-5D version). Each dimension has 5 levels of response. (Level 1); slight; moderate; severe; and extreme problems (Level 5). here are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).

    Measured: preoperative, 1month and 3months post surgery

  5. Fear and Depression

    Evaluate the core complaints of fear and depression (without physical complaints) using the HADS questionnaire. Seven questions related to fear and seven questions related to depression. Every question can be answered with 0-1-2-3. If the score for the questions with fear is >8, this will indicate a psychiatric condition. If the score for the questions related to depression >8, this will indicate a psychiatric condition.

    Measured: preoperative, 1month and 3months post surgery

  6. State anxiety and fear predisposition

    Evaluation of the state anxiety and fear disposition using the Stai-Trait questionnaire. The range of scoring goes from a minimum of 20 untill a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80)

    Measured: preoperative, 1month and 3months post surgery

  7. Pain complaints

    The MPI questionnaire part 1 measures the impact of pain on an individual's life, quality of social support and general activity. Each item is rated on a 0-6 scale, and the scoreds for each subscale are calculated by adding the score for each item in that subscale, devided by the number of items that subscale to yeald a mean score.

    Measured: preoperative, 1month and 3months post surgery if the NRS ≥ 3

  8. Neuropatic pain

    Evaluation of the presence of neuropatic pain components using the DN4 quesionnaire. When the score ≥ 4, neuropatic pain is likely.

    Measured: preoperative, 1month and 3months post surgery if the NRS ≥ 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start22 Dec 2022
  3. Primary completion6 Mar 2024
  4. Study completion6 Mar 2024

Resources

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
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526976
Sponsor's protocol ID
EDGE002575
Acronym
PERISCOPEcare
Status last verified
Jun 2024
First submitted
31 Aug 2022
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wildemeersch D, Wauters E, Roelant E, Verhaegen I, De Clerck GR, Dankerlui R, Saldien V, Hans GH. A Novel Presurgical Risk Prediction Model for Chronic Post-Surgical Pain in Adults Undergoing Surgical Procedures: Development and Internal Validation of the P4-Prevoque Questionnaire [PERISCOPE Trial]. J Pain Res. 2025 Jul 5;18:3415-3428. doi: 10.2147/JPR.S525692. eCollection 2025.

    PubMed 40636548

  • Wildemeersch D, Meeus I, Wauters E, Vanlommel L, Roelant E, Dankerlui R, Saldien V, Vandervelde L, Verhaegen I, Hans GH. Evaluating the Predictive Value of a Short Preoperative Holistic Risk Factor Screening Questionnaire in Preventing Persistent Pain in Elective Adult Surgery: Study Protocol for a Prospective Observational Pragmatic Trial [PERISCOPE]. J Pain Res. 2023 Dec 13;16:4281-4287. doi: 10.2147/JPR.S439824. eCollection 2023.

    PubMed 38107366

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Chronic Post-Surgical, run by University Hospital, Antwerp at 2 sites 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Cut-off determination (time frame: preoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05526976, which also lists 2 linked publications.

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 10 Jun 2024.

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