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Chronic Post Surgical Pain-Cardiac

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06382077
Acronym
CPSP-Cardiac
Enrollment
2442
Registered
2024-04-24
Start date
2024-05-07
Completion date
2026-02-15
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post-surgical Pain

Keywords

cardiac anesthesia, chronic post-surgical pain, nerve blocks

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.

Interventions

None listed

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of chronic postsurgical painPostoperative 3rd and 6th monthsThe 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

MeasureTime frameDescription
Postoperative opioid consumption in the first 24 hoursPostoperative day 1Morphine consumption in the first 24 hours will be measured.
Postoperative pain scoresPostoperative day 1Pain 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."
The incidences of postoperative nausea and vomitingPostoperative day 1The 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
The number of patients with side effects and complicationsThe time from surgery to the time of discharge to the home; an average of 14 daysThe number of patients have any side effects and complications will be recorded.
Time to extubationPostoperative Day 1After the operation, the time until the patient is extubated will be recorded.
Length of stay in the intensive care unitThe time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 daysTotal duration of stay in intensive care unit (ICU) will be recorded
Length of stay in the hospitalMeasured in days admitted in the hospital, an average of 14 daysTheir stay in the hospital will be recorded.
Chronic pain status at 3 and 6 months90 and 180 days after surgeryAfter 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.
Psychological assessment90 and 180 days after surgeryThe patient's anxiety and depression status will be assessed using the Hospital Anxiety and Depression Scale.
Quality of life assessment90 and 180 days after surgeryPain Self-Efficacy Questionnaire will be used to assess the influence of chronic pain on the individual's daily life.
Postoperative complications at 3 and 6 months90 and 180 days after surgeryThe 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORBurhan DOST, Assoc.Prof

Ondokuz Mayıs University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026