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

NCT07629453 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-05

No results posted yet for this study

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
  • Acute Postoperative Pain
  • Cardiac Surgery

Interventions

PROCEDURE

Standard Multimodal Opioid-Based Analgesia

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

PROCEDURE

Regional Anesthesia-Based Analgesia

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.

Sponsors & Collaborators

  • East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia

    collaborator UNKNOWN

  • Uppsala University Hospital

    collaborator OTHER

  • Kočan Ladislav

    lead OTHER

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-01
Completion
2029-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07629453 on ClinicalTrials.gov