PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

NCT05526976 | Completed

• 1 other identifier: EDGE002575
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 2

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

Conditions

Pain, Chronic Post-Surgical

Keywords

Persistent postoperative pain

Outcome Measures

Primary Outcomes (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

  preoperative

Secondary Outcomes (8)

• Postoperative pain

  postoperative (day 0 or 1day post surgery)

• Persistent postoperative pain

  1 month and 3months post surgery

• The use of opioids

  1month and 3months post surgery

• The patients well-being

  preoperative, 1month and 3months post surgery

• Fear and Depression

  preoperative, 1month and 3months post surgery

Interventions

PERISCOPE-care OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (2)

UZA

Edegem, Antwerp, 2650, Belgium

Location

University Hospital Antwerp

Antwerp, Belgium

Location

Related Publications (2)

• 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.

  PMID: 40636548 DERIVED

• 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.

  PMID: 38107366 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Davina Wildemeersch

  Staff Member

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: December 22, 2022
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

BE (2)