Chronic Post Surgical Pain-Cardiac

NCT06382077 | Completed

• 1 other identifier: CPSP5502
• Study Type: observational
• Target: 2,442
• Locations: 1 country
• Sites: 29

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.

Conditions

Chronic Post-surgical Pain

Keywords

cardiac anesthesia; chronic post-surgical pain; nerve blocks

Outcome Measures

Primary Outcomes (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.

  Postoperative 3rd and 6th months

Secondary Outcomes (11)

• Postoperative opioid consumption in the first 24 hours

  Postoperative day 1

• Postoperative pain scores

  Postoperative day 1

• The incidences of postoperative nausea and vomiting

  Postoperative day 1

• The number of patients with side effects and complications

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

• Time to extubation

  Postoperative Day 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (29)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Adiyaman Üniversitesi

Adıyaman, Turkey (Türkiye)

Location

Ankara University

Ankara, Turkey (Türkiye)

Location

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Hacettepe Üniversitesi

Ankara, Turkey (Türkiye)

Location

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Antalya Eah

Antalya, Turkey (Türkiye)

Location

Bursa City Hospital

Bursa, Turkey (Türkiye)

Location

Bursa Yuksek Ihtisas Eah

Bursa, Turkey (Türkiye)

Location

Uludağ Üniversitesi

Bursa, Turkey (Türkiye)

Location

Canakkale University

Çanakkale, Turkey (Türkiye)

Location

Hitit University

Çorum, Turkey (Türkiye)

Location

Denizli Dh

Denizli, Turkey (Türkiye)

Location

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Süleyman Demirel Üniversitesi

Isparta, Turkey (Türkiye)

Location

Acibadem Atasehir Hospital

Istanbul, Turkey (Türkiye)

Location

Basahsehir Cam and Sakura Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Kartal Kosuyolu Eah

Istanbul, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

Medipol Mega Hospital

Istanbul, Turkey (Türkiye)

Location

İzmir Katip Çelebi University

Izmir, Turkey (Türkiye)

Location

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Kocaeli Şehir Hastanesi

Kocaeli, Turkey (Türkiye)

Location

Mersin University

Mersin, Turkey (Türkiye)

Location

Muğla Eah

Muğla, Turkey (Türkiye)

Location

Samsun University

Samsun, Turkey (Türkiye)

Location

Karadeniz Teknik University

Trabzon, Turkey (Türkiye)

Location

Trabzon Ahi Avran Eah

Trabzon, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37501517 BACKGROUND

• 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.

  PMID: 37192204 BACKGROUND

• 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.

  PMID: 36581838 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Burhan DOST, Assoc.Prof

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 7, 2024
• Primary Completion: August 1, 2025
• Study Completion: February 15, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (29)