AzTrials
AzTrials

Chronic Post-surgical PainCROPSNCT07629453

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

A study testing Standard Multimodal Opioid-Based Analgesia and Regional Anesthesia-Based Analgesia in people with Chronic Post-surgical Pain and Acute Postoperative Pain, run by Kočan Ladislav.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard Multimodal Opioid-Based Analgesia and Regional Anesthesia-Based Analgesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ladislav Kočan, assoc. prof, MD, PhD contact

+421557891110

lkocan@vusch.sk

Peter Kostič, MD PhD contact

peter.kostic@uu.se

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Standard Multimodal Opioid-Based Analgesia, Regional Anesthesia-Based Analgesia
Keywords
chronic post-surgical pain, cardiac surgery, regional anesthesia, postoperative analgesia
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Multimodal Opioid-Based AnalgesiaProcedure or surgery

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

  • Regional Anesthesia-Based AnalgesiaProcedure or 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.

Study groups in NCT07629453
Study groupRoleWhat they receive
Standard Multimodal Opioid-Based AnalgesiaActive comparatorParticipants will receive standard multimodal opioid-based perioperative analgesia according to institutional cardiac surgery pain management protocols.
Receives: Procedure: Standard Multimodal Opioid-Based Analgesia
Regional Anesthesia-Based AnalgesiaExperimentalParticipants will receive regional anesthesia-based perioperative analgesia including chest wall plane block techniques in combination with multimodal analgesia during cardiac surgery.
Receives: Procedure: Regional Anesthesia-Based Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Chronic Post-Surgical Pain at 3 Months

    Presence of chronic post-surgical pain assessed 3 months after surgery using the Brief Pain Inventory questionnaire and pain intensity evaluation.

    Measured: 3 months after surgery

Secondary outcomes (12)
  1. Postoperative Pain Intensity

    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.

    Measured: Postoperative days 1-7

  2. Perioperative Opioid Consumption

    Total perioperative and postoperative opioid consumption expressed as morphine milligram equivalents (MME).

    Measured: Postoperative days 1-7

  3. Brief Pain Inventory Score Changes

    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.

    Measured: Baseline, 1 week, and 3 months after surgery

  4. Validation of Pain Chronification Risk Assessment Questionnaire

    Predictive performance of the questionnaire for chronic post-surgical pain development assessed using ROC analysis, sensitivity, and specificity.

    Measured: Baseline assessment with 3-month follow-up

  5. Quality of Life Assessment

    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.

    Measured: Baseline and 3 months after surgery

  6. Perioperative Vasopressor Requirement

    Requirement for perioperative vasopressor support assessed by norepinephrine administration duration and cumulative dose during surgery and intensive care unit stay.

    Measured: From surgery until postoperative day 7

  7. Cardiopulmonary Bypass and Surgical Parameters

    Operative and cardiopulmonary bypass parameters including duration of surgery, cardiopulmonary bypass time, and aortic cross-clamp time.

    Measured: Intraoperative period

  8. Duration of Mechanical Ventilation

    Duration of postoperative mechanical ventilation measured in hours from ICU admission until successful extubation.

    Measured: Postoperative period through day 7

  9. Intensive Care Unit Length of Stay

    Length of stay in the intensive care unit measured in days.

    Measured: Up to 30 days after surgery

  10. Hospital Length of Stay

    Total postoperative hospital length of stay measured in days.

    Measured: Up to 30 days after surgery

  11. Postoperative Complications

    Number of participants experiencing postoperative complications including respiratory, cardiovascular, neurological, infectious, or surgical complications.

    Measured: Up to 30 days after surgery

  12. In-Hospital Mortality

    Number of participants who die during the index hospitalization.

    Measured: Up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629453
Sponsor's protocol ID
CROPS-INT-RCT-2026
Acronym
CROPS
Status last verified
Jun 2026
First submitted
17 May 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Martuliak I, Golubnitschaja O, Chvala L, Kapalla M, Ferencik M, Bubeliny M, Venglarcik M, Kocan L. Pain chronification risk assessment: advanced phenotyping and scoring for prediction and treatments tailored to individualized patient profile. EPMA J. 2024 Nov 15;15(4):739-750. doi: 10.1007/s13167-024-00383-3. eCollection 2024 Dec.

    PubMed 39635026

Questions about this trial

What is this clinical trial studying?

A study testing Standard Multimodal Opioid-Based Analgesia and Regional Anesthesia-Based Analgesia in people with Chronic Post-surgical Pain and Acute Postoperative Pain, run by Kočan Ladislav.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ladislav Kočan, assoc. prof, MD, PhD (+421557891110, lkocan@vusch.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Chronic Post-Surgical Pain at 3 Months (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07629453, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in