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NCT Number: NCT06382077

Chronic Post Surgical Pain-Cardiac

The CPSP-Cardiac is a large, multi-center, observational study with the aim to investigate the incidence of chronic pain in the 3rd month postoperatively in cardiac surgery and its affecting factors.

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Key information

Conditions

Chronic Post-surgical Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayis University, Samsun, Atakum, Turkey (Türkiye)

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About this study

Cardiovascular diseases pose a significant global health concern, particularly among the elderly population, leading to a surge in surgical interventions. Enhanced Recovery After Surgery (ERAS®) protocols, specifically ERAS® Cardiac, target improved perioperative pain management to optimize patient outcomes. Effective pain control aims to alleviate acute discomfort, prevent chronic pain development, facilitate early mobilization, reduce hospital stays, and enhance patient satisfaction and functional recovery. While pain intensity peaks within the initial days following cardiac surgery and gradually subsides, inadequate acute pain management can predispose patients to chronic pain, impairing their quality of life. Multimodal opioid-sparing analgesia strategies are recommended, with recent advancements in ultrasound-guided regional anesthesia techniques showing promise in enhancing acute pain relief and reducing opioid consumption, particularly through truncal fascial plane blocks and parasternal blocks. However, the impact of these techniques on chronic postsurgical pain remains incompletely understood. This multicenter study aims to investigate the incidence of chronic postsurgical pain following cardiac surgery, exploring the influence of various factors and their implications on patients' quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients will be undergoing a first-time cardiac surgery involving a median sternotomy, including coronary artery bypass grafting (CABG) and all open-heart procedures, such as valvular repairs/replacement.
  • patients between the ages of 18-80 years
  • American Society of Anesthesiologists (ASA) Physical Status score of II-III
  • patients will also sign the written informed consent form

Exclusion criteria

  • patients scheduled for minimally invasive cardiac surgery,
  • patients with BMI>40,
  • patients who undergone thoracotomy,
  • patients with alcohol and drug addiction,
  • patients with severe dysfunction in a significant organ (e.g., presence of severe hepatic and renal disease),
  • patients who undergone emergency and redo surgeries,
  • patients who cannot be extubated within the first 8 hours postoperatively,
  • patients have a severe psychiatric diseases such as psychosis or dementia that restrict cooperation with the patient (patients who cannot evaluate verbal numerical pain scales),
  • patients who are pregnant and breastfeeding,
  • patients who cannot be reached by phone during the postoperative follow-up periods
  • patients who cannot communicate in the native language.

Treatment and study plan

Primary outcomes

  1. The incidence of chronic postsurgical pain

    Time frame: Postoperative 3rd and 6th months

    The incidence of chronic postsurgical pain (CPSP) in the third month following cardiac surgery along with identifying the factors that influence it. CPSP as pain that (A) emerges after surgery, (B) is distinct from pre-procedural pain, (C) is not caused by other factors, and (D) persists for at least three months.

Secondary outcomes

  1. Postoperative opioid consumption in the first 24 hours

    Time frame: Postoperative day 1

    Morphine consumption in the first 24 hours will be measured.

  2. Postoperative pain scores

    Time frame: Postoperative day 1

    Pain at rest and during activity (coughing and deep breathing) will be assessed by numerical rating scale (NRS) scores at 0, 3, 6, 12, and 24 hours after extubation. The NRS is an 11-point numeric scale that ranges from 0 to 10. The NRS is an 11-point scale consisting of integers from 0 to 10: 0 indicates "no pain" and 10 indicates "the worst pain ever possible."

  3. The incidences of postoperative nausea and vomiting

    Time frame: Postoperative day 1

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, and 24 hours after extubation. The PONV scale is 0 = none, 1 = mild nausea, 2 = moderate nausea, 3 = vomiting once, and 4 = vomiting more than once

  4. The number of patients with side effects and complications

    Time frame: The time from surgery to the time of discharge to the home; an average of 14 days

    The number of patients have any side effects and complications will be recorded.

  5. Time to extubation

    Time frame: Postoperative Day 1

    After the operation, the time until the patient is extubated will be recorded.

  6. Length of stay in the intensive care unit

    Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days

    Total duration of stay in intensive care unit (ICU) will be recorded

  7. Length of stay in the hospital

    Time frame: Measured in days admitted in the hospital, an average of 14 days

    Their stay in the hospital will be recorded.

  8. Chronic pain status at 3 and 6 months

    Time frame: 90 and 180 days after surgery

    After discharge, patients will be contacted at 3 and 6 months. Pain intensity and status will be assessed using the Brief Pain Inventory-Short Form, and the character of pain will be evaluated using the Leeds Assessment of Neuropathic Signs and Symptoms Pain Questionnaire score.

  9. Psychological assessment

    Time frame: 90 and 180 days after surgery

    The patient's anxiety and depression status will be assessed using the Hospital Anxiety and Depression Scale.

  10. Quality of life assessment

    Time frame: 90 and 180 days after surgery

    Pain Self-Efficacy Questionnaire will be used to assess the influence of chronic pain on the individual's daily life.

  11. Postoperative complications at 3 and 6 months

    Time frame: 90 and 180 days after surgery

    The severity of complications will be evaluated using the 'Clavien-Dindo' classification. Additionally, the 'Comprehensive Complication Index' (https://www.cci-calculator.com/cciCalculator) will be used to evaluate the patient's overall postoperative morbidity.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Determination of the Frequency and Affecting Factors of Chronic Postsurgical Pain After Cardiac Surgery: A Multicenter, Observational Study

Acronym: CPSP-Cardiac

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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