PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

Completed

• Conditions: Pain, Chronic Post-Surgical

• Registration Number: NCT05526976
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-02
• Study Start: 2022-12-22
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cut-off determination	preoperative	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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	postoperative (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.
The patients well-being	preoperative, 1month and 3months post surgery	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).
State anxiety and fear predisposition	preoperative, 1month and 3months post surgery	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)
Pain complaints	preoperative, 1month and 3months post surgery if the NRS ≥ 3	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.
Neuropatic pain	preoperative, 1month and 3months post surgery if the NRS ≥ 3	Evaluation of the presence of neuropatic pain components using the DN4 quesionnaire. When the score ≥ 4, neuropatic pain is likely.
Persistent postoperative pain	1 month and 3months post surgery	Determination 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 opioids	1month and 3months post surgery	Need for daily intake of opioids (started postoperative) after surgery
Fear and Depression	preoperative, 1month and 3months post surgery	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.

Trial Locations

Locations (2)

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium

UZA; 🇧🇪 Edegem, Antwerp, Belgium