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

2026年6月4日 更新者:Kočan Ladislav

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.

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

180

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Ladislav Kočan, assoc. prof, MD, PhD
  • 電話番号:+421557891110
  • メール:lkocan@vusch.sk

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Standard Multimodal Opioid-Based Analgesia
Participants will receive standard multimodal opioid-based perioperative analgesia according to institutional cardiac surgery pain management protocols.
Standard perioperative pain management including opioid-based multimodal analgesia administered according to institutional cardiac surgery protocols.
実験的:Regional Anesthesia-Based Analgesia
Participants will receive regional anesthesia-based perioperative analgesia including chest wall plane block techniques in combination with multimodal analgesia during cardiac 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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Chronic Post-Surgical Pain at 3 Months
時間枠:3 months after surgery
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Pain Intensity
時間枠:Postoperative days 1-7
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.
Postoperative days 1-7
Perioperative Opioid Consumption
時間枠:Postoperative days 1-7
Total perioperative and postoperative opioid consumption expressed as morphine milligram equivalents (MME).
Postoperative days 1-7
Brief Pain Inventory Score Changes
時間枠:Baseline, 1 week, and 3 months after surgery
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.
Baseline, 1 week, and 3 months after surgery
Validation of Pain Chronification Risk Assessment Questionnaire
時間枠:Baseline assessment with 3-month follow-up
Predictive performance of the questionnaire for chronic post-surgical pain development assessed using ROC analysis, sensitivity, and specificity.
Baseline assessment with 3-month follow-up
Quality of Life Assessment
時間枠:Baseline and 3 months after surgery
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.
Baseline and 3 months after surgery
Perioperative Vasopressor Requirement
時間枠:From surgery until postoperative day 7
Requirement for perioperative vasopressor support assessed by norepinephrine administration duration and cumulative dose during surgery and intensive care unit stay.
From surgery until postoperative day 7
Cardiopulmonary Bypass and Surgical Parameters
時間枠:Intraoperative period
Operative and cardiopulmonary bypass parameters including duration of surgery, cardiopulmonary bypass time, and aortic cross-clamp time.
Intraoperative period
Duration of Mechanical Ventilation
時間枠:Postoperative period through day 7
Duration of postoperative mechanical ventilation measured in hours from ICU admission until successful extubation.
Postoperative period through day 7
Intensive Care Unit Length of Stay
時間枠:Up to 30 days after surgery
Length of stay in the intensive care unit measured in days.
Up to 30 days after surgery
Hospital Length of Stay
時間枠:Up to 30 days after surgery
Total postoperative hospital length of stay measured in days.
Up to 30 days after surgery
Postoperative Complications
時間枠:Up to 30 days after surgery
Number of participants experiencing postoperative complications including respiratory, cardiovascular, neurological, infectious, or surgical complications.
Up to 30 days after surgery
In-Hospital Mortality
時間枠:Up to 30 days after surgery
Number of participants who die during the index hospitalization.
Up to 30 days after surgery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア: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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2026年5月17日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月4日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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