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Chronic Post-surgical PainCPSP-CardiacNCT06382077

Chronic Post Surgical Pain-Cardiac

An observational study of Chronic Post-surgical Pain, run by Ondokuz Mayıs University at 29 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Post-surgical Pain
How many people
2,442 participants
Where
29 sitesTurkey (Türkiye)
Study dates
7 May 2024to 15 Feb 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 11Show fewer
  • 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.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Turkey (Türkiye)29 sites

  • Adiyaman Üniversitesi

    Adıyaman

  • Ankara University

    Ankara

  • Bilkent City Hospital

    Ankara

  • Hacettepe Üniversitesi

    Ankara

  • Akdeniz University

    Antalya

  • Antalya Eah

    Antalya

  • Bursa City Hospital

    Bursa

  • Bursa Yuksek Ihtisas Eah

    Bursa

  • Uludağ Üniversitesi

    Bursa

  • Canakkale University

    Çanakkale

  • Hitit University

    Çorum

  • Denizli Dh

    Denizli

  • Ataturk University

    Erzurum

  • Süleyman Demirel Üniversitesi

    Isparta

  • Acibadem Atasehir Hospital

    Istanbul

  • Basahsehir Cam and Sakura Hospital

    Istanbul

  • Istanbul University

    Istanbul

  • Kartal Kosuyolu Eah

    Istanbul

  • Marmara University

    Istanbul

  • Medipol Mega Hospital

    Istanbul

  • İzmir Katip Çelebi University

    Izmir

  • Kocaeli University

    Kocaeli

  • Kocaeli Şehir Hastanesi

    Kocaeli

  • Mersin University

    Mersin

  • Muğla Eah

    Muğla

  • Ondokuz Mayis University

    Samsun, Atakum, 55139

  • Samsun University

    Samsun

  • Karadeniz Teknik University

    Trabzon

  • Trabzon Ahi Avran Eah

    Trabzon

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
cardiac anesthesia, chronic post-surgical pain, nerve blocks
Medical subject headings
Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of chronic postsurgical pain

    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.

    Measured: Postoperative 3rd and 6th months

Secondary outcomes (11)

  1. Postoperative opioid consumption in the first 24 hours

    Morphine consumption in the first 24 hours will be measured.

    Measured: Postoperative day 1

  2. Postoperative pain scores

    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."

    Measured: Postoperative day 1

  3. The incidences of postoperative nausea and vomiting

    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

    Measured: Postoperative day 1

  4. The number of patients with side effects and complications

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

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

  5. Time to extubation

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

    Measured: Postoperative Day 1

  6. Length of stay in the intensive care unit

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

    Measured: 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

  7. Length of stay in the hospital

    Their stay in the hospital will be recorded.

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

  8. Chronic pain status at 3 and 6 months

    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.

    Measured: 90 and 180 days after surgery

  9. Psychological assessment

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

    Measured: 90 and 180 days after surgery

  10. Quality of life assessment

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

    Measured: 90 and 180 days after surgery

  11. Postoperative complications at 3 and 6 months

    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.

    Measured: 90 and 180 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start7 May 2024
  3. Primary completion1 Aug 2025
  4. Study completion15 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,442 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382077
Sponsor's protocol ID
CPSP5502
Acronym
CPSP-Cardiac
Status last verified
Feb 2026
First submitted
19 Apr 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maessen T, Korir N, Van de Velde M, Kennes J, Pogatzki-Zahn E, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy. Pain management after cardiac surgery via median sternotomy: A systematic review with procedure-specific postoperative pain management (PROSPECT) recommendations. Eur J Anaesthesiol. 2023 Oct 1;40(10):758-768. doi: 10.1097/EJA.0000000000001881. Epub 2023 Jul 19.

    PubMed 37501517

  • Xiao MZX, Khan JS, Dana E, Rao V, Djaiani G, Richebe P, Katz J, Wong D, Clarke H. Prevalence and Risk Factors for Chronic Postsurgical Pain after Cardiac Surgery: A Single-center Prospective Cohort Study. Anesthesiology. 2023 Sep 1;139(3):309-320. doi: 10.1097/ALN.0000000000004621.

    PubMed 37192204

  • Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.

    PubMed 36581838

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Post-surgical Pain, run by Ondokuz Mayıs University at 29 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of chronic postsurgical pain (time frame: Postoperative 3rd and 6th months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06382077, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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