Health TrialsbyHealthPanel

CROPS Study: Chronification of Post-Surgical Pain and Risk Assessment

ConditionsChronic Post-surgical PainAcute Postoperative PainCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKočan Ladislav

About this trial

Chronic post-surgical pain (CPSP) represents a major clinical problem associated with impaired functional recovery, reduced quality of life, prolonged opioid use, and increased healthcare utilization. The mechanisms underlying pain chronification are multifactorial and involve complex interactions among surgical trauma, inflammatory responses, central sensitization, neuroimmune activation, and psychosocial risk factors.

The CROPS study (Chronification of Post-Surgical Pain and Risk Assessment) is a prospective multicenter randomized controlled trial designed to evaluate the impact of perioperative analgesic strategies on the development of chronic post-surgical pain and to validate a novel questionnaire-based pain chronification risk assessment tool in adult patients undergoing cardiac surgery.

Participants will be randomized to receive either standard multimodal opioid-based perioperative analgesia or regional anesthesia-based perioperative analgesia incorporating chest wall plane block techniques, including erector spinae plane block, paravertebral block, or PECS block, according to institutional practice.

The study will compare postoperative pain intensity, opioid consumption, postoperative recovery, postoperative complications, health-related quality of life, and the incidence of chronic post-surgical pain at 3 months after surgery. In parallel, the predictive performance of the pain chronification risk assessment questionnaire will be evaluated using discrimination and calibration analyses.

The study is conducted as an investigator-initiated academic collaboration between the East Slovakia Institute of Cardiovascular Diseases, Košice, Slovakia, and Uppsala University Hospital, Uppsala, Sweden.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

coronary artery bypass grafting (CABG)

aortic valve replacement or repair

mitral valve replacement or repair

Disqualifiers

Emergency surgery

Cognitive impairment preventing study participation

Serious psychiatric illness interfering with study participation

Language barrier preventing questionnaire completion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Multimodal Opioid-Based Analgesia

    Procedure/Surgery

    Standard perioperative pain management including opioid-based multimodal analgesia administered according to institutional cardiac surgery protocols.

  • Regional Anesthesia-Based Analgesia

    Procedure/Surgery

    Regional anesthesia-based perioperative analgesia including chest wall plane block techniques such as erector spinae plane block, PECS block, or paravertebral block in combination with multimodal analgesia during cardiac surgery.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Standard Multimodal Opioid-Based AnalgesiaActive comparator 1 intervention
Group B: Regional Anesthesia-Based AnalgesiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Chronic Post-Surgical Pain at 3 Months

Presence of chronic post-surgical pain assessed 3 months after surgery using the Brief Pain Inventory questionnaire and pain intensity evaluation.

Time frame
3 months after surgery

Secondary outcomes

1

Postoperative Pain Intensity

Postoperative pain intensity assessed using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain), assessed four times daily during the first postoperative week.

Time frame
Postoperative days 1-7
2

Perioperative Opioid Consumption

Total perioperative and postoperative opioid consumption expressed as morphine milligram equivalents (MME).

Time frame
Postoperative days 1-7
3

Brief Pain Inventory Score Changes

Changes in Brief Pain Inventory (BPI) questionnaire scores ranging from 0 to 10, where higher scores indicate worse pain severity and pain interference, assessed between baseline, postoperative week 1, and 3-month follow-up.

Time frame
Baseline, 1 week, and 3 months after surgery
4

Validation of Pain Chronification Risk Assessment Questionnaire

Predictive performance of the questionnaire for chronic post-surgical pain development assessed using ROC analysis, sensitivity, and specificity.

Time frame
Baseline assessment with 3-month follow-up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kočan Ladislav

Lead sponsor

Pavol Jozef Safarik University

Sponsor institution

East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia

Collaborator

Uppsala University Hospital

Collaborator

Source ClinicalTrials.gov

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