Determination of the Frequency and Affecting Factors of Chronic Postsurgical Pain After Cardiac Surgery: A Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,442
- 试验地点
- 29
- 主要终点
- The incidence of chronic postsurgical pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The incidence of chronic postsurgical pain
时间窗: 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.
次要结局
- Time to extubation(Postoperative Day 1)
- Length of stay in the hospital(Measured in days admitted in the hospital, an average of 14 days)
- Chronic pain status at 3 and 6 months(90 and 180 days after surgery)
- 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)
- Quality of life assessment(90 and 180 days after surgery)
- Postoperative opioid consumption in the first 24 hours(Postoperative day 1)
- Postoperative pain scores(Postoperative day 1)
- Psychological assessment(90 and 180 days after surgery)
- The incidences of postoperative nausea and vomiting(Postoperative day 1)
- 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)
- Postoperative complications at 3 and 6 months(90 and 180 days after surgery)
研究者
BURHAN DOST
Coordinating Investigator
Ondokuz Mayıs University