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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKočan Ladislav

About this 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.

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.

Eligibility criteria

Qualifiers

Age ≥18 years

coronary artery bypass grafting (CABG)

aortic valve replacement or repair

mitral valve replacement or repair

Disqualifiers

Emergency surgery

Cognitive impairment preventing study participation

Serious psychiatric illness interfering with study participation

Language barrier preventing questionnaire completion

Trial design

Treatments tested in this trial

  • Standard Multimodal Opioid-Based Analgesia
  • Regional Anesthesia-Based Analgesia

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Kočan Ladislav

Lead sponsor

Pavol Jozef Safarik University

Sponsor institution

East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia

Collaborator

Uppsala University Hospital

Collaborator