- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07629453
CROPS Study: Chronification of Post-Surgical Pain and Risk Assessment (CROPS)
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ladislav Kočan, assoc. prof, MD, PhD
- Numer telefonu: +421557891110
- E-mail: lkocan@vusch.sk
Kopia zapasowa kontaktu do badania
- Nazwa: Peter Kostič, MD PhD
- E-mail: peter.kostic@uu.se
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Chronic Post-Surgical Pain at 3 Months
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Pain Intensity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Up to 30 days after surgery
|
Total postoperative hospital length of stay measured in days.
|
Up to 30 days after surgery
|
|
Postoperative Complications
Ramy czasowe: 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
Ramy czasowe: Up to 30 days after surgery
|
Number of participants who die during the index hospitalization.
|
Up to 30 days after surgery
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: 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
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CROPS-INT-RCT-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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