The Effect of Ultrasound-Guided Fascial Plane Blocks on Postoperative Pulmonary Complications in Patients Undergoing Major Abdominal Surgery: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of postoperative pulmonary complications (PPCs)
研究概览
简要总结
This prospective observational study aims to evaluate whether the use of ultrasound-guided fascial plane blocks is associated with a lower incidence of postoperative pulmonary complications in adult patients undergoing elective major abdominal surgery under general anesthesia.
Patients will be observed in two groups based on routine clinical practice: those who receive an ultrasound-guided fascial plane block for postoperative analgesia and those managed with other standard analgesic methods. The choice of analgesic technique will be determined by the responsible anesthesia team and not influenced by the study.
Postoperative pulmonary complications occurring within the first 7 days after surgery will be recorded using reopening the European Perioperative Clinical Outcome (EPCO) criteria. Secondary outcomes will include unplanned intensive care unit admission, length of hospital stay, and 30-day mortality. No additional procedures or interventions will be performed for research purposes.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Scheduled for elective major abdominal surgery (e.g., colorectal, hepatobiliary, pancreatic, or gastric surgery)
- •ASA physical status II-III
- •Ability to provide written informed consent
- •Planned use of general anesthesia with or without adjunct regional techniques
排除标准
- •Refusal or inability to provide informed consent
- •Known allergy or contraindication to local anesthetics
- •Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia
- •Infection at the site of planned block
- •Pre-existing chronic opioid use or chronic pain syndrome
- •Severe hepatic, renal, or cardiac failure (e.g., Child-Pugh C, end-stage renal disease, EF <30%)
- •Cognitive impairment or severe dementia preventing adequate pain assessment
- •Emergency surgery
- •Body mass index (BMI > 40 kg/m²)
研究组 & 干预措施
Fascial Plane Block Group
Patients undergoing elective major abdominal surgery who receive an ultrasound-guided fascial plane block at the end of surgery as part of routine clinical practice for postoperative analgesia. The decision to perform the block is made by the responsible anesthesia team and is not influenced by the study protocol.
Control Group
Patients undergoing elective major abdominal surgery who do not receive an ultrasound-guided fascial plane block and are managed with other routine postoperative analgesic methods, including epidural analgesia, intravenous patient-controlled analgesia, or oral analgesics, according to standard clinical practice.
结局指标
主要结局
Incidence of postoperative pulmonary complications (PPCs)
时间窗: Within the first 7 postoperative days
Postoperative pulmonary complications will be defined and recorded according to the European Perioperative Clinical Outcome (EPCO) criteria.
次要结局
未报告次要终点
研究者
Arif Timuroğlu, MD
Specialist in Anesthesiology and Intensive Care
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital