Chronic Post Surgical Pain-Cardiac
- Conditions
- Chronic Post-surgical Pain
- Registration Number
- NCT06382077
- Lead Sponsor
- Ondokuz Mayıs University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1176
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of chronic postsurgical pain 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.
- Secondary Outcome Measures
Name Time Method Time to extubation Postoperative Day 1 After the operation, the time until the patient is extubated will be recorded.
Length of stay in the hospital Measured in days admitted in the hospital, an average of 14 days Their stay in the hospital will be recorded.
Chronic pain status at 3 and 6 months 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.
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 The number of patients have any side effects and complications will be recorded.
Quality of life assessment 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.
Postoperative opioid consumption in the first 24 hours Postoperative day 1 Morphine consumption in the first 24 hours will be measured.
Postoperative pain scores 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."
Psychological assessment 90 and 180 days after surgery The patient's anxiety and depression status will be assessed using the Hospital Anxiety and Depression Scale.
The incidences of postoperative nausea and vomiting 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
Length of stay in the intensive care unit 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
Postoperative complications at 3 and 6 months 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.
Trial Locations
- Locations (36)
Uludağ Üniversitesi
🇹🇷Bursa, Turkey
Denizli Dh
🇹🇷Denizli, Turkey
Sanko Üniversitesi
🇹🇷Gaziantep, Turkey
Bursa City Hospital
🇹🇷Bursa, Turkey
Ondokuz Mayis University
🇹🇷Samsun, Atakum, Turkey
Baskent University
🇹🇷Adana, Turkey
Adiyaman Üniversitesi
🇹🇷Adıyaman, Turkey
Ankara University
🇹🇷Ankara, Turkey
Bilkent City Hospital
🇹🇷Ankara, Turkey
Hacettepe Üniversitesi
🇹🇷Ankara, Turkey
Akdeniz University
🇹🇷Antalya, Turkey
Bursa Yuksek Ihtisas Eah
🇹🇷Bursa, Turkey
Antalya Eah
🇹🇷Antalya, Turkey
Düzce Üniversitesi
🇹🇷Düzce, Turkey
Acibadem Atasehir Hospital
🇹🇷Istanbul, Turkey
Ataturk University
🇹🇷Erzurum, Turkey
Süleyman Demirel Üniversitesi
🇹🇷Isparta, Turkey
Basahsehir Cam and Sakura Hospital
🇹🇷Istanbul, Turkey
Istanbul University
🇹🇷Istanbul, Turkey
Cemil Taşçioğlu Şehir Hastanesi
🇹🇷Istanbul, Turkey
Kartal Kosuyolu Eah
🇹🇷Istanbul, Turkey
Koç University Hospital
🇹🇷Istanbul, Turkey
Marmara University
🇹🇷Istanbul, Turkey
Kocaeli University
🇹🇷Kocaeli, Turkey
Kocaeli Şehir Hastanesi
🇹🇷Kocaeli, Turkey
Medipol Mega Hospital
🇹🇷İ̇stanbul, Turkey
Mersin University
🇹🇷Mersin, Turkey
Muğla Eah
🇹🇷Muğla, Turkey
Samsun University
🇹🇷Samsun, Turkey
Recep Tayyip Erdoğan Üniversitesi
🇹🇷Rize, Turkey
Burhan Dost
🇹🇷Samsun, Turkey
Karadeniz Teknik University
🇹🇷Trabzon, Turkey
Trabzon Ahi Avran Eah
🇹🇷Trabzon, Turkey
Canakkale University
🇹🇷Çanakkale, Turkey
Hitit University
🇹🇷Çorum, Turkey
Şanliurfa Eah
🇹🇷Şanlıurfa, Turkey