Investigating chronic pain after cardiac surgery
Determination of the Frequency and Affecting Factors of Chronic Postsurgical Pain After Cardiac Surgery: A Multicenter, Observational Study
This study looks at how many people still have pain three months after their first heart surgery and what factors might affect their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1176 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ondokuz Mayıs University Academic / other |
| Locations | 36 sites (Samsun, Atakum and 35 other locations) |
| Trial ID | NCT06382077 on ClinicalTrials.gov |
What this trial studies
The CPSP-Cardiac is a large, multi-center observational study aimed at understanding the incidence of chronic post-surgical pain in patients three months after cardiac surgery. It focuses on patients undergoing first-time cardiac surgeries, such as coronary artery bypass grafting and valvular repairs, and examines various factors that may influence pain outcomes. The study utilizes Enhanced Recovery After Surgery (ERAS®) protocols to improve pain management and patient recovery. By analyzing the effectiveness of multimodal analgesia strategies, including ultrasound-guided regional anesthesia, the study seeks to provide insights into preventing chronic pain and enhancing quality of life for cardiac surgery patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 undergoing first-time cardiac surgery involving a median sternotomy.
Not a fit: Patients scheduled for minimally invasive cardiac surgery or those with severe organ dysfunction or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that reduce the incidence of chronic pain in cardiac surgery patients.
How similar studies have performed: Other studies have shown promise in using multimodal analgesia and regional anesthesia techniques to improve acute pain management, but the long-term effects on chronic pain in this specific population remain less explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Samsun, Atakum and 35 other locations
- Ondokuz Mayis University — Samsun, Atakum, Turkey (Recruiting)
- Baskent University — Adana, Turkey (Recruiting)
- Adiyaman Üniversitesi — Adıyaman, Turkey (Recruiting)
- Ankara University — Ankara, Turkey (Recruiting)
- Bilkent City Hospital — Ankara, Turkey (Recruiting)
- Hacettepe Üniversitesi — Ankara, Turkey (Recruiting)
- Akdeniz University — Antalya, Turkey (Recruiting)
- Antalya Eah — Antalya, Turkey (Recruiting)
- Bursa City Hospital — Bursa, Turkey (Recruiting)
- Bursa Yuksek Ihtisas Eah — Bursa, Turkey (Recruiting)
- Uludağ Üniversitesi — Bursa, Turkey (Recruiting)
- Denizli Dh — Denizli, Turkey (Recruiting)
- Düzce Üniversitesi — Düzce, Turkey (Recruiting)
- Ataturk University — Erzurum, Turkey (Recruiting)
- Sanko Üniversitesi — Gaziantep, Turkey (Recruiting)
- Süleyman Demirel Üniversitesi — Isparta, Turkey (Recruiting)
- Acibadem Atasehir Hospital — Istanbul, Turkey (Recruiting)
- Basahsehir Cam and Sakura Hospital — Istanbul, Turkey (Recruiting)
- Cemil Taşçioğlu Şehir Hastanesi — Istanbul, Turkey (Recruiting)
- Istanbul University — Istanbul, Turkey (Recruiting)
- Kartal Kosuyolu Eah — Istanbul, Turkey (Recruiting)
- Koç University Hospital — Istanbul, Turkey (Recruiting)
- Marmara University — Istanbul, Turkey (Recruiting)
- Medipol Mega Hospital — İ̇stanbul, Turkey (Recruiting)
- Kocaeli University — Kocaeli, Turkey (Recruiting)
- Kocaeli Şehir Hastanesi — Kocaeli, Turkey (Recruiting)
- Mersin University — Mersin, Turkey (Recruiting)
- Muğla Eah — Muğla, Turkey (Recruiting)
- Recep Tayyip Erdoğan Üniversitesi — Rize, Turkey (Recruiting)
- Burhan Dost — Samsun, Turkey (Not_yet_recruiting)
- Samsun University — Samsun, Turkey (Recruiting)
- Karadeniz Teknik University — Trabzon, Turkey (Recruiting)
- Trabzon Ahi Avran Eah — Trabzon, Turkey (Recruiting)
- Canakkale University — Çanakkale, Turkey (Recruiting)
- Hitit University — Çorum, Turkey (Recruiting)
- Şanliurfa Eah — Şanlıurfa, Turkey (Recruiting)
Study contacts
- Study coordinator: Burhan DOST, Assoc.Prof
- Email: burhandost@hotmail.com
- Phone: +903623121919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.