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

4 juin 2026 mis à jour par: Kočan Ladislav

Chronification of Post-Surgical Pain and Validation of a Novel Risk Assessment Tool: A Prospective Multicenter Randomized Controlled 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.

Aperçu de l'étude

Description détaillée

Chronic post-surgical pain (CPSP) is a common and clinically significant complication following cardiac surgery and is associated with impaired functional recovery, reduced quality of life, prolonged opioid exposure, and increased healthcare utilization. Despite substantial advances in perioperative care, a considerable proportion of patients continue to experience persistent pain for months after surgery. The pathophysiology of CPSP is multifactorial and involves complex interactions among surgical tissue injury, peripheral and central sensitization, neuroinflammatory activation, altered pain modulation pathways, and psychosocial vulnerability factors.

Optimization of perioperative analgesia has been proposed as a strategy to reduce nociceptive input, attenuate perioperative stress responses, and potentially decrease the risk of pain chronification. Regional anesthesia techniques, particularly chest wall plane blocks, have demonstrated beneficial effects on acute postoperative pain control and opioid-sparing outcomes in cardiac surgery. However, their influence on long-term pain outcomes and the development of CPSP remains incompletely understood.

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 postoperative recovery and chronic pain development 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 parameters, postoperative complications, health-related quality of life, and the incidence of chronic post-surgical pain at 3 months after surgery. Particular emphasis will be placed on evaluating whether regional anesthesia-based analgesic strategies reduce perioperative opioid exposure and improve both short-term and long-term patient-centered outcomes.

In parallel, the study aims to validate a novel questionnaire-based pain chronification risk assessment tool intended to identify patients at increased risk of developing CPSP. Predictive performance of the questionnaire will be evaluated using receiver operating characteristic (ROC) analysis, including assessment of area under the curve (AUC), sensitivity, specificity, discrimination, and calibration performance.

The primary outcome measures are the incidence of chronic post-surgical pain at 3 months following surgery and the predictive accuracy of the pain chronification risk assessment questionnaire. Secondary outcomes include postoperative pain intensity, perioperative opioid consumption expressed as morphine milligram equivalents, postoperative nausea and vomiting, postoperative recovery parameters, respiratory complications, duration of mechanical ventilation, intensive care unit length of stay, hospital length of stay, postoperative complications, in-hospital mortality, and changes in quality-of-life and pain-related functional outcome measures.

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

Type d'étude

Interventionnel

Inscription (Estimé)

180

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Ladislav Kočan, assoc. prof, MD, PhD
  • Numéro de téléphone: +421557891110
  • E-mail: lkocan@vusch.sk

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age ≥18 years
  • Elective cardiac surgery requiring median sternotomy, including:
  • coronary artery bypass grafting (CABG)
  • aortic valve replacement or repair
  • mitral valve replacement or repair
  • ascending aorta surgery
  • Ability to understand study information
  • Ability to provide written informed consent
  • Expected postoperative hospital stay longer than 3 days
  • Availability for follow-up at 1 week and 3 months after surgery

Exclusion Criteria:

  • Emergency surgery
  • Cognitive impairment preventing study participation
  • Serious psychiatric illness interfering with study participation
  • Language barrier preventing questionnaire completion
  • Participation in another interventional study affecting pain outcomes
  • Reoperation for postoperative bleeding
  • Severe chronic renal failure
  • Allergy or contraindication to study medication or regional anesthesia techniques
  • Pregnancy or breastfeeding
  • Chronic opioid therapy exceeding 60 mg morphine equivalents daily
  • Extensive emergency aortic surgery (e.g., Thoraflex implantation for acute aortic dissection)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Standard Multimodal Opioid-Based Analgesia
Participants will receive standard multimodal opioid-based perioperative analgesia according to institutional cardiac surgery pain management protocols.
Standard perioperative pain management including opioid-based multimodal analgesia administered according to institutional cardiac surgery protocols.
Expérimental: Regional Anesthesia-Based Analgesia
Participants will receive regional anesthesia-based perioperative analgesia including chest wall plane block techniques in combination with multimodal analgesia during cardiac 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Chronic Post-Surgical Pain at 3 Months
Délai: 3 months after surgery
Presence of chronic post-surgical pain assessed 3 months after surgery using the Brief Pain Inventory questionnaire and pain intensity evaluation.
3 months after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative Pain Intensity
Délai: Postoperative days 1-7
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.
Postoperative days 1-7
Perioperative Opioid Consumption
Délai: Postoperative days 1-7
Total perioperative and postoperative opioid consumption expressed as morphine milligram equivalents (MME).
Postoperative days 1-7
Brief Pain Inventory Score Changes
Délai: Baseline, 1 week, and 3 months after surgery
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.
Baseline, 1 week, and 3 months after surgery
Validation of Pain Chronification Risk Assessment Questionnaire
Délai: Baseline assessment with 3-month follow-up
Predictive performance of the questionnaire for chronic post-surgical pain development assessed using ROC analysis, sensitivity, and specificity.
Baseline assessment with 3-month follow-up
Quality of Life Assessment
Délai: Baseline and 3 months after surgery
Quality of life evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) and EQ Visual Analogue Scale (EQ-VAS), where higher scores indicate better health status.
Baseline and 3 months after surgery
Perioperative Vasopressor Requirement
Délai: From surgery until postoperative day 7
Requirement for perioperative vasopressor support assessed by norepinephrine administration duration and cumulative dose during surgery and intensive care unit stay.
From surgery until postoperative day 7
Cardiopulmonary Bypass and Surgical Parameters
Délai: Intraoperative period
Operative and cardiopulmonary bypass parameters including duration of surgery, cardiopulmonary bypass time, and aortic cross-clamp time.
Intraoperative period
Duration of Mechanical Ventilation
Délai: Postoperative period through day 7
Duration of postoperative mechanical ventilation measured in hours from ICU admission until successful extubation.
Postoperative period through day 7
Intensive Care Unit Length of Stay
Délai: Up to 30 days after surgery
Length of stay in the intensive care unit measured in days.
Up to 30 days after surgery
Hospital Length of Stay
Délai: Up to 30 days after surgery
Total postoperative hospital length of stay measured in days.
Up to 30 days after surgery
Postoperative Complications
Délai: Up to 30 days after surgery
Number of participants experiencing postoperative complications including respiratory, cardiovascular, neurological, infectious, or surgical complications.
Up to 30 days after surgery
In-Hospital Mortality
Délai: Up to 30 days after surgery
Number of participants who die during the index hospitalization.
Up to 30 days after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chaise d'étude: Peter Kostic, MD, PhD, Department of Heart and Lung Diseases, Unit for Cardiothoracic Surgery, Anesthesia and Intensive Care, Uppsala University Hospital, 751 85 Uppsala, Sweden

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 juin 2029

Dates d'inscription aux études

Première soumission

17 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data sharing has not yet been determined. Data sharing policies will be evaluated after study completion in accordance with institutional regulations, ethical approvals, and patient privacy requirements.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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