PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain (PERISCOPEcare)

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

Study Overview

• Status: Completed
• Conditions: Pain, Chronic Post-Surgical
• Intervention / Treatment: Other: PERISCOPE-care

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.

• Study Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • University Hospital Antwerp
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • UZA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Determination with numeric rating schale, NRS (numeric rating scale). Values from 0-10 with 10 being the highest pain you can have.	postoperative (day 0 or 1day post surgery)
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.	1 month and 3months post surgery
The use of opioids	Need for daily intake of opioids (started postoperative) after surgery	1month and 3months post surgery
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).	preoperative, 1month and 3months post surgery
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.	preoperative, 1month and 3months post surgery
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)	preoperative, 1month and 3months post surgery
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.	preoperative, 1month and 3months post surgery if the NRS ≥ 3
Neuropatic pain	Evaluation of the presence of neuropatic pain components using the DN4 quesionnaire. When the score ≥ 4, neuropatic pain is likely.	preoperative, 1month and 3months post surgery if the NRS ≥ 3

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Davina Wildemeersch, Staff Member

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Persistent postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: EDGE002575

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No