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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07629453
Acronym
CROPS
Enrollment
180
Registered
2026-06-05
Start date
2026-09-01
Completion date
2029-06-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Postoperative Pain, Cardiac Surgery, Chronic Post-surgical Pain

Keywords

chronic post-surgical pain, cardiac surgery, regional anesthesia, postoperative analgesia

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREStandard Multimodal Opioid-Based Analgesia

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

PROCEDURERegional Anesthesia-Based Analgesia

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.

Sponsors

Kočan Ladislav
Lead SponsorOTHER
East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia
CollaboratorUNKNOWN
Uppsala University Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Due to the nature of regional anesthesia interventions, masking of participants and care providers is not feasible.

Intervention model description

Participants undergoing elective cardiac surgery will be randomized in a parallel assignment design to receive either conventional multimodal opioid-based perioperative analgesia or regional anesthesia-based chest wall plane block techniques as part of perioperative pain management.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Chronic Post-Surgical Pain at 3 Months3 months after surgeryPresence of chronic post-surgical pain assessed 3 months after surgery using the Brief Pain Inventory questionnaire and pain intensity evaluation.

Secondary

MeasureTime frameDescription
Postoperative Pain IntensityPostoperative days 1-7Postoperative 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.
Perioperative Opioid ConsumptionPostoperative days 1-7Total perioperative and postoperative opioid consumption expressed as morphine milligram equivalents (MME).
Brief Pain Inventory Score ChangesBaseline, 1 week, and 3 months after surgeryChanges 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.
Validation of Pain Chronification Risk Assessment QuestionnaireBaseline assessment with 3-month follow-upPredictive performance of the questionnaire for chronic post-surgical pain development assessed using ROC analysis, sensitivity, and specificity.
Quality of Life AssessmentBaseline and 3 months after surgeryQuality 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.
Perioperative Vasopressor RequirementFrom surgery until postoperative day 7Requirement for perioperative vasopressor support assessed by norepinephrine administration duration and cumulative dose during surgery and intensive care unit stay.
Cardiopulmonary Bypass and Surgical ParametersIntraoperative periodOperative and cardiopulmonary bypass parameters including duration of surgery, cardiopulmonary bypass time, and aortic cross-clamp time.
Duration of Mechanical VentilationPostoperative period through day 7Duration of postoperative mechanical ventilation measured in hours from ICU admission until successful extubation.
Intensive Care Unit Length of StayUp to 30 days after surgeryLength of stay in the intensive care unit measured in days.
Hospital Length of StayUp to 30 days after surgeryTotal postoperative hospital length of stay measured in days.
Postoperative ComplicationsUp to 30 days after surgeryNumber of participants experiencing postoperative complications including respiratory, cardiovascular, neurological, infectious, or surgical complications.
In-Hospital MortalityUp to 30 days after surgeryNumber of participants who die during the index hospitalization.

Contacts

CONTACTLadislav Kočan, assoc. prof, MD, PhD
lkocan@vusch.sk+421557891110
CONTACTPeter Kostič, MD PhD
peter.kostic@uu.se
STUDY_CHAIRPeter Kostic, MD, PhD

Department of Heart and Lung Diseases, Unit for Cardiothoracic Surgery, Anesthesia and Intensive Care, Uppsala University Hospital, 751 85 Uppsala, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026