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

NCT07629453 | Not Yet Recruiting

• 1 other identifier: CROPS-INT-RCT-2026
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (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.

  3 months after surgery

Secondary Outcomes (12)

• Postoperative Pain Intensity

  Postoperative days 1-7

• Perioperative Opioid Consumption

  Postoperative days 1-7

• Brief Pain Inventory Score Changes

  Baseline, 1 week, and 3 months after surgery

• Validation of Pain Chronification Risk Assessment Questionnaire

  Baseline assessment with 3-month follow-up

• Quality of Life Assessment

  Baseline and 3 months after surgery

Study Arms (2)

Standard Multimodal Opioid-Based Analgesia

ACTIVE COMPARATOR

Participants will receive standard multimodal opioid-based perioperative analgesia according to institutional cardiac surgery pain management protocols.

Procedure: Standard Multimodal Opioid-Based Analgesia

Regional Anesthesia-Based Analgesia

EXPERIMENTAL

Participants will receive regional anesthesia-based perioperative analgesia including chest wall plane block techniques in combination with multimodal analgesia during cardiac surgery.

Procedure: Regional Anesthesia-Based Analgesia

Interventions

Standard Multimodal Opioid-Based Analgesia PROCEDURE

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

Standard Multimodal Opioid-Based Analgesia

Regional Anesthesia-Based Analgesia PROCEDURE

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.

Regional Anesthesia-Based Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kočan Ladislav: lead
• Uppsala University Hospital: collaborator
• East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia: collaborator

Related Publications (1)

• 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.

  PMID: 39635026 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Ladislav Kočan, assoc. prof, MD, PhD

CONTACT

+421557891110; lkocan@vusch.sk

Peter Kostič, MD PhD

CONTACT

peter.kostic@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of regional anesthesia interventions, masking of participants and care providers is not feasible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Study Chair

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share