Chronic Post Surgical Pain-Cardiac

NCT ID: NCT06382077

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2442 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2026-02-25

Brief 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.

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.

Conditions

Chronic Post-surgical Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

BURHAN DOST

Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burhan DOST, Assoc.Prof

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Baskent University

Adana, , Turkey (Türkiye)

Adiyaman Üniversitesi

Adıyaman, , Turkey (Türkiye)

Ankara University

Ankara, , Turkey (Türkiye)

Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Hacettepe Üniversitesi

Ankara, , Turkey (Türkiye)

Akdeniz University

Antalya, , Turkey (Türkiye)

Antalya Eah

Antalya, , Turkey (Türkiye)

Bursa City Hospital

Bursa, , Turkey (Türkiye)

Bursa Yuksek Ihtisas Eah

Bursa, , Turkey (Türkiye)

Uludağ Üniversitesi

Bursa, , Turkey (Türkiye)

Canakkale University

Çanakkale, , Turkey (Türkiye)

Hitit University

Çorum, , Turkey (Türkiye)

Denizli Dh

Denizli, , Turkey (Türkiye)

Düzce Üniversitesi

Düzce, , Turkey (Türkiye)

Ataturk University

Erzurum, , Turkey (Türkiye)

Sanko Üniversitesi

Gaziantep, , Turkey (Türkiye)

Süleyman Demirel Üniversitesi

Isparta, , Turkey (Türkiye)

Acibadem Atasehir Hospital

Istanbul, , Turkey (Türkiye)

Basahsehir Cam and Sakura Hospital

Istanbul, , Turkey (Türkiye)

Cemil Taşçioğlu Şehir Hastanesi

Istanbul, , Turkey (Türkiye)

Istanbul University

Istanbul, , Turkey (Türkiye)

Kartal Kosuyolu Eah

Istanbul, , Turkey (Türkiye)

Koç University Hospital

Istanbul, , Turkey (Türkiye)

Marmara University

Istanbul, , Turkey (Türkiye)

Medipol Mega Hospital

Istanbul, , Turkey (Türkiye)

İzmir Katip Çelebi University

Izmir, , Turkey (Türkiye)

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Kocaeli Şehir Hastanesi

Kocaeli, , Turkey (Türkiye)

Mersin University

Mersin, , Turkey (Türkiye)

Muğla Eah

Muğla, , Turkey (Türkiye)

Recep Tayyip Erdoğan Üniversitesi

Rize, , Turkey (Türkiye)

Burhan Dost

Samsun, , Turkey (Türkiye)

Samsun University

Samsun, , Turkey (Türkiye)

Şanliurfa Eah

Sanliurfa, , Turkey (Türkiye)

Karadeniz Teknik University

Trabzon, , Turkey (Türkiye)

Trabzon Ahi Avran Eah

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 37501517 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37192204 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36581838 (View on PubMed)

Other Identifiers

CPSP5502

Identifier Type: -

Identifier Source: org_study_id