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PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05526976
Acronym
PERISCOPEcare
Enrollment
660
Registered
2022-09-02
Start date
2022-12-22
Completion date
2024-03-06
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic Post-Surgical

Keywords

Persistent postoperative pain

Brief 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

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.

Interventions

OTHERPERISCOPE-care

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).

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cut-off determinationpreoperativeCut-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

Secondary

MeasureTime frameDescription
Persistent postoperative pain1 month and 3months post surgeryDetermination of persistent postoperative pain via NRS (numeric rating scale). Values from 0-10 with 10 being the highest pain you can have.
The use of opioids1month and 3months post surgeryNeed for daily intake of opioids (started postoperative) after surgery
The patients well-beingpreoperative, 1month and 3months post surgeryEvaluation 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).
Postoperative painpostoperative (day 0 or 1day post surgery)Determination with numeric rating schale, NRS (numeric rating scale). Values from 0-10 with 10 being the highest pain you can have.
State anxiety and fear predispositionpreoperative, 1month and 3months post surgeryEvaluation 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)
Pain complaintspreoperative, 1month and 3months post surgery if the NRS ≥ 3The 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.
Neuropatic painpreoperative, 1month and 3months post surgery if the NRS ≥ 3Evaluation of the presence of neuropatic pain components using the DN4 quesionnaire. When the score ≥ 4, neuropatic pain is likely.
Fear and Depressionpreoperative, 1month and 3months post surgeryEvaluate 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026