Chronic Post Surgical Pain-Cardiac (CPSP-Cardiac)

February 17, 2026 updated by: BURHAN DOST, Ondokuz Mayıs University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2442

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Adıyaman, Turkey (Türkiye)
        • Adiyaman Üniversitesi
      • Ankara, Turkey (Türkiye)
        • Bilkent City Hospital
      • Ankara, Turkey (Türkiye)
        • Ankara University
      • Ankara, Turkey (Türkiye)
        • Hacettepe Universitesi
      • Antalya, Turkey (Türkiye)
        • Akdeniz University
      • Antalya, Turkey (Türkiye)
        • Antalya Eah
      • Bursa, Turkey (Türkiye)
        • Bursa City Hospital
      • Bursa, Turkey (Türkiye)
        • Bursa Yuksek Ihtisas EAH
      • Bursa, Turkey (Türkiye)
        • Uludağ Üniversitesi
      • Denizli, Turkey (Türkiye)
        • Denizli Dh
      • Erzurum, Turkey (Türkiye)
        • Ataturk University
      • Isparta, Turkey (Türkiye)
        • Süleyman Demirel Üniversitesi
      • Istanbul, Turkey (Türkiye)
        • Marmara University
      • Istanbul, Turkey (Türkiye)
        • Istanbul University
      • Istanbul, Turkey (Türkiye)
        • Acibadem Atasehir Hospital
      • Istanbul, Turkey (Türkiye)
        • Basahsehir Cam and Sakura Hospital
      • Istanbul, Turkey (Türkiye)
        • Kartal Kosuyolu Eah
      • Istanbul, Turkey (Türkiye)
        • Medipol Mega Hospital
      • Izmir, Turkey (Türkiye)
        • Izmir Katip Celebi University
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli University
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli Şehir Hastanesi
      • Mersin, Turkey (Türkiye)
        • Mersin University
      • Muğla, Turkey (Türkiye)
        • Muğla EAH
      • Samsun, Turkey (Türkiye)
        • Samsun University
      • Trabzon, Turkey (Türkiye)
        • Karadeniz Teknik University
      • Trabzon, Turkey (Türkiye)
        • Trabzon Ahi Avran Eah
      • Çanakkale, Turkey (Türkiye)
        • Canakkale University
      • Çorum, Turkey (Türkiye)
        • Hitit University
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55139
        • Ondokuz Mayis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The target population of 1176 cardiac surgery patients will be recruited from participating hospital sites. Patients eligible for our study will be undergoing a first-time cardiac surgery involving a median sternotomy, including CABG and all open-heart procedures, such as valvular repairs/replacement

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Postoperative 3rd and 6th months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to extubation
Time Frame: Postoperative Day 1
After the operation, the time until the patient is extubated will be recorded.
Postoperative Day 1
Postoperative opioid consumption in the first 24 hours
Time Frame: Postoperative day 1
Morphine consumption in the first 24 hours will be measured.
Postoperative day 1
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."
Postoperative day 1
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
Postoperative day 1
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.
The time from surgery to the time of discharge to the home; an average of 14 days
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
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
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.
Measured in days admitted in the hospital, an average of 14 days
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.
90 and 180 days after surgery
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.
90 and 180 days after surgery
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.
90 and 180 days after surgery
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.
90 and 180 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ondokuz Mayıs University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Burhan DOST, Assoc.Prof, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPSP5502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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