Clinical trial NCT05526976: PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain
Official title: PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic Post-Surgical
Keywords: Persistent postoperative pain
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The first 560 patients who will undergo an elective surgery and have a preop consultation with a pain physician.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cut-off determination
timeFrame: preoperative
Secondary outcomes:
measure: Postoperative pain
timeFrame: postoperative (day 0 or 1day post surgery)
measure: Persistent postoperative pain
timeFrame: 1 month and 3months post surgery
measure: The use of opioids
timeFrame: 1month and 3months post surgery
measure: The patients well-being
timeFrame: preoperative, 1month and 3months post surgery
measure: Fear and Depression
timeFrame: preoperative, 1month and 3months post surgery
measure: State anxiety and fear predisposition
timeFrame: preoperative, 1month and 3months post surgery
measure: Pain complaints
timeFrame: preoperative, 1month and 3months post surgery if the NRS ≥ 3
measure: Neuropatic pain
timeFrame: preoperative, 1month and 3months post surgery if the NRS ≥ 3
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
state: Antwerp
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: Staff Member
name: Davina Wildemeersch
role: PRINCIPAL_INVESTIGATOR
References: