CROPS Study: Chronification of Post-Surgical Pain and Risk Assessment
Not yet recruitingNot applicableNCT07629453
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Chronification of Post-Surgical Pain and Validation of a Novel Risk Assessment Tool: A Prospective Multicenter Randomized Controlled Trial
- Conditions
- Chronic Post-surgical Pain
- Acute Postoperative Pain
- Cardiac Surgery
- Interventions
- Procedure: Standard Multimodal Opioid-Based Analgesia
- Procedure: Regional Anesthesia-Based Analgesia
- Sponsor
- Kočan Ladislav
- Collaborators
- East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia; Uppsala University Hospital
- Organization
- Pavol Jozef Safarik University
- Start date
- 2026-09-01
- Primary completion
- 2028-12-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07629453