Clinical trial NCT06382077: Chronic Post Surgical Pain-Cardiac
Official title: Determination of the Frequency and Affecting Factors of Chronic Postsurgical Pain After Cardiac Surgery: A Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Post-surgical Pain
Keywords: cardiac anesthesia
chronic post-surgical pain
nerve blocks
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 1176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.

Primary outcomes:
measure: The incidence of chronic postsurgical pain
timeFrame: Postoperative 3rd and 6th months
Secondary outcomes:
measure: Postoperative opioid consumption in the first 24 hours
timeFrame: Postoperative day 1
measure: Postoperative pain scores
timeFrame: Postoperative day 1
measure: The incidences of postoperative nausea and vomiting
timeFrame: Postoperative day 1
measure: The number of patients with side effects and complications
timeFrame: The time from surgery to the time of discharge to the home; an average of 14 days
measure: Time to extubation
timeFrame: Postoperative Day 1
measure: Length of stay in the intensive care unit
timeFrame: 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
measure: Length of stay in the hospital
timeFrame: Measured in days admitted in the hospital, an average of 14 days
measure: Chronic pain status at 3 and 6 months
timeFrame: 90 and 180 days after surgery
measure: Psychological assessment
timeFrame: 90 and 180 days after surgery
measure: Quality of life assessment
timeFrame: 90 and 180 days after surgery
measure: Postoperative complications at 3 and 6 months
timeFrame: 90 and 180 days after surgery
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
city: Adana
country: Turkey
facility: Baskent University
city: Adıyaman
country: Turkey
facility: Adiyaman Üniversitesi
city: Ankara
country: Turkey
facility: Ankara University
city: Ankara
country: Turkey
facility: Bilkent City Hospital
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi
city: Antalya
country: Turkey
facility: Akdeniz University
city: Antalya
country: Turkey
facility: Antalya Eah
city: Bursa
country: Turkey
facility: Bursa City Hospital
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Eah
city: Bursa
country: Turkey
facility: Uludağ Üniversitesi
city: Denizli
country: Turkey
facility: Denizli Dh
city: Düzce
country: Turkey
facility: Düzce Üniversitesi
city: Erzurum
country: Turkey
facility: Ataturk University
city: Gaziantep
country: Turkey
facility: Sanko Üniversitesi
city: Isparta
country: Turkey
facility: Süleyman Demirel Üniversitesi
city: Istanbul
country: Turkey
facility: Acibadem Atasehir Hospital
city: Istanbul
country: Turkey
facility: Basahsehir Cam and Sakura Hospital
city: Istanbul
country: Turkey
facility: Cemil Taşçioğlu Şehir Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Eah
city: Istanbul
country: Turkey
facility: Koç University Hospital
city: Istanbul
country: Turkey
facility: Marmara University
city: İ̇stanbul
country: Turkey
facility: Medipol Mega Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University
city: Kocaeli
country: Turkey
facility: Kocaeli Şehir Hastanesi
city: Mersin
country: Turkey
facility: Mersin University
city: Muğla
country: Turkey
facility: Muğla Eah
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan Üniversitesi
city: Samsun
country: Turkey
facility: Burhan Dost
city: Samsun
country: Turkey
facility: Samsun University
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University
city: Trabzon
country: Turkey
facility: Trabzon Ahi Avran Eah
city: Çanakkale
country: Turkey
facility: Canakkale University
city: Çorum
country: Turkey
facility: Hitit University
city: Şanlıurfa
country: Turkey
facility: Şanliurfa Eah
Study officials:
affiliation: Ondokuz Mayıs University
name: Burhan DOST, Assoc.Prof
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.