Chronic Post-surgical Pain Clinical Trial
— CPSP-CardiacOfficial title:
Determination of the Frequency and Affecting Factors of Chronic Postsurgical Pain After Cardiac Surgery: A Multicenter, Observational Study
NCT number | NCT06382077 |
Other study ID # | CPSP5502 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 7, 2024 |
Est. completion date | October 25, 2025 |
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.
Status | Recruiting |
Enrollment | 1176 |
Est. completion date | October 25, 2025 |
Est. primary completion date | May 7, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Baskent University | Adana | |
Turkey | Adiyaman Üniversitesi | Adiyaman | |
Turkey | Ankara University | Ankara | |
Turkey | Bilkent City Hospital | Ankara | |
Turkey | Hacettepe Üniversitesi | Ankara | |
Turkey | Akdeniz University | Antalya | |
Turkey | Antalya Eah | Antalya | |
Turkey | Bursa City Hospital | Bursa | |
Turkey | Bursa Yuksek Ihtisas Eah | Bursa | |
Turkey | Uludag Üniversitesi | Bursa | |
Turkey | Canakkale University | Çanakkale | |
Turkey | Hitit University | Çorum | |
Turkey | Denizli Dh | Denizli | |
Turkey | Düzce Üniversitesi | Düzce | |
Turkey | Ataturk University | Erzurum | |
Turkey | Sanko Üniversitesi | Gaziantep | |
Turkey | Medipol Mega Hospital | I?stanbul | |
Turkey | Süleyman Demirel Üniversitesi | Isparta | |
Turkey | Acibadem Atasehir Hospital | Istanbul | |
Turkey | Basahsehir Cam and Sakura Hospital | Istanbul | |
Turkey | Cemil Tasçioglu Sehir Hastanesi | Istanbul | |
Turkey | Istanbul University | Istanbul | |
Turkey | Kartal Kosuyolu Eah | Istanbul | |
Turkey | Koç University Hospital | Istanbul | |
Turkey | Marmara University | Istanbul | |
Turkey | Kocaeli Sehir Hastanesi | Kocaeli | |
Turkey | Kocaeli University | Kocaeli | |
Turkey | Mersin University | Mersin | |
Turkey | Mugla Eah | Mugla | |
Turkey | Recep Tayyip Erdogan Üniversitesi | Rize | |
Turkey | Burhan Dost | Samsun | |
Turkey | Ondokuz Mayis University | Samsun | Atakum |
Turkey | Samsun University | Samsun | |
Turkey | Sanliurfa Eah | Sanliurfa | |
Turkey | Karadeniz Teknik University | Trabzon | |
Turkey | Trabzon Ahi Avran Eah | Trabzon |
Lead Sponsor | Collaborator |
---|---|
Ondokuz Mayis University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative opioid consumption in the first 24 hours | Morphine consumption in the first 24 hours will be measured. | Postoperative day 1 | |
Secondary | 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." | Postoperative day 1 | |
Secondary | 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 | Postoperative day 1 | |
Secondary | The number of patients with side effects and complications | The number of patients have any side effects and complications will be recorded. | The time from surgery to the time of discharge to the home; an average of 14 days | |
Secondary | Time to extubation | After the operation, the time until the patient is extubated will be recorded. | Postoperative Day 1 | |
Secondary | Length of stay in the intensive care unit | Total duration of stay in intensive care unit (ICU) will be recorded | 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 | |
Secondary | Length of stay in the hospital | Their stay in the hospital will be recorded. | Measured in days admitted in the hospital, an average of 14 days | |
Secondary | 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. | 90 and 180 days after surgery | |
Secondary | Psychological assessment | The patient's anxiety and depression status will be assessed using the Hospital Anxiety and Depression Scale. | 90 and 180 days after surgery | |
Secondary | Quality of life assessment | Pain Self-Efficacy Questionnaire will be used to assess the influence of chronic pain on the individual's daily life. | 90 and 180 days after surgery | |
Secondary | 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. | 90 and 180 days after surgery |
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