Chronic Post Surgical Pain-Cardiac

Chronic Post-surgical Pain Clinical Trial

— CPSP-Cardiac  

Official title:

Determination of the Frequency and Affecting Factors of Chronic Postsurgical Pain After Cardiac Surgery: A Multicenter, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382077
• Other study ID #: CPSP5502
• Status: Recruiting
• Start date: May 7, 2024
• Est. completion date: October 25, 2025

Study information

• Verified date: May 2024
• Source: Ondokuz Mayis University
• Contact: Burhan DOST, Assoc.Prof
• Phone: +903623121919
• Email: burhandost[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Post-surgical Pain
• Pain, Postoperative

Locations

Country	Name	City	State
Turkey	Baskent University	Adana
Turkey	Ankara University	Ankara
Turkey	Bilkent City Hospital	Ankara
Turkey	Akdeniz University	Antalya
Turkey	Antalya Eah	Antalya
Turkey	Bursa City Hospital	Bursa
Turkey	Bursa Yuksek Ihtisas Eah	Bursa
Turkey	Canakkale University	Çanakkale
Turkey	Hitit University	Çorum
Turkey	Ataturk University	Erzurum
Turkey	Medipol Mega Hospital	I?stanbul
Turkey	Acibadem Atasehir Hospital	Istanbul
Turkey	Basahsehir Cam and Sakura Hospital	Istanbul
Turkey	Istanbul University	Istanbul
Turkey	Kartal Kosuyolu Eah	Istanbul
Turkey	Koç University Hospital	Istanbul
Turkey	Marmara University	Istanbul
Turkey	Kocaeli University	Kocaeli
Turkey	Mersin University	Mersin
Turkey	Mugla Eah	Mugla
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

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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