Not Yet RecruitingNot Applicable

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

180 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This CROPS study is looking at why some people develop long-term pain after cardiac surgery — since it's focused on understanding risk factors rather than testing a new treatment, what would actually be done to me as a participant, and would my care be any different from standard cardiac surgery care?
2The study is measuring chronic post-surgical pain at the 3-month mark after surgery — does that mean I'd need to come back for follow-up appointments or answer questionnaires over that whole period, and is that something you think would be realistic given my recovery situation?
3Since this trial is listed as 'not yet recruiting,' do you know when it's expected to open and whether waiting to see if I qualify would affect the timing of my cardiac surgery or my overall treatment plan?
4This study is in a phase labeled 'NA,' which suggests it's more of an observational or data-collection study than one testing a drug or device — so could you explain what risks, if any, there are to participating compared to just having the surgery without being enrolled?
5Given that chronic post-surgical pain affects some cardiac surgery patients, are there things you'd already recommend doing before or after my surgery to lower that risk, regardless of whether I end up joining this study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Chronic Post-Surgical Pain at 3 Months

Timeframe: 3 months after surgery

Trial details

NCT IDNCT07629453

SponsorKočan Ladislav

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-01

Contact for this trial

Ladislav Kočan, assoc. prof, MD, PhD

+421557891110 lkocan@vusch.sk

View on ClinicalTrials.gov More Chronic Post-surgical Pain trials