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临床试验/NCT07211529
NCT07211529招募中不适用

Perioperative Paravertebral Block Reduces Postoperative Complications in Thoracic Surgery: An Observational Study

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Postoperative Complications

研究概览

简要总结

This study aims to evaluate the clinical association between intraoperative paravertebral block and the reduction of postoperative complications following thoracic surgery.

详细描述

This study is designed as an observational investigation combining both retrospective and prospective components, focusing on patients undergoing thoracic surgery, primarily pulmonary and mediastinal procedures.

Retrospective analysis: We will collect data from patients across multiple campuses of Tongji Hospital who previously underwent thoracic surgery with intraoperative paravertebral block. These cases will be retrospectively analyzed to explore the association between paravertebral block and the reduction of postoperative complications.

Prospective evaluation: For patients enrolled prospectively, we will collect perioperative biochemical parameters, including MMP3, neutrophils, leukocytes, PCT, CRP, and other relevant regulatory factors. Postoperative outcomes will be assessed by recording cough and pain scores, as well as time to first flatus and defecation at 24 and 48 hours after surgery. In addition, patients will be followed for 30 days to document the incidence of postoperative complications.

Clinical correlation: The association between the measured biomarkers and patient outcomes will be systematically evaluated to determine their clinical relevance in predicting prognosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •Male or female participants aged 18 years or older.
  • •Scheduled to undergo thoracic surgery via Video-Assisted Thoracoscopic Surgery (VATS) or Robotic-Assisted Thoracoscopic Surgery (RATS), including wedge resection, segmentectomy, lobectomy, or mediastinal surgery.
  • •Signed informed consent obtained prior to study participation. -

排除标准

  • •Patients who refuse to provide informed consent.
  • •Anesthesiologists who have not received training in ultrasound-guided paravertebral block (PVB-US).
  • •History of ipsilateral thoracic surgery.
  • •Conversion to open thoracotomy during the procedure.
  • •Patients who did not complete the scheduled surgery due to disease progression or medical reasons.
  • •Patients who are lost to follow-up or refuse postoperative follow-up. -

研究组 & 干预措施

Paravertebral Block (PVB)Group

Experimental

Participants in this arm will receive a paravertebral nerve block (PVB) performed intraoperatively under ultrasound guidance prior to the thoracic surgical procedure. The block will target the relevant thoracic vertebral levels corresponding to the surgical site. Standard local anesthetic agents will be administered according to institutional protocols. This intervention aims to provide perioperative analgesia, reduce postoperative pain, and potentially decrease the incidence of postoperative complications. All participants will also receive standard intraoperative monitoring and anesthesia management as per routine clinical practice.

干预措施: Paravertebral Block (PVB) (Procedure)

Control Group

No Intervention

Participants in this arm will receive standard perioperative analgesia without the administration of a paravertebral block. Pain management will follow institutional protocols, which may include systemic opioids, non-steroidal anti-inflammatory drugs (NSAIDs), or other conventional analgesic methods. All participants will undergo the thoracic surgical procedure under standard intraoperative monitoring and anesthesia management as per routine clinical practice. This arm serves as the control group for evaluating the clinical effects of intraoperative paravertebral block on postoperative pain and complication rates.

结局指标

主要结局

Postoperative Complications

时间窗: 1 to 3 months postoperatively

Postoperative complications following thoracic surgery will be assessed as the primary outcome. These complications include pulmonary infection, respiratory failure, pleural effusion, atelectasis, bronchospasm, pneumothorax, aspiration-induced lung injury, pulmonary embolism, bronchopleural fistula, and acute respiratory distress syndrome (ARDS). The incidence of these complications will be systematically recorded and analyzed to evaluate the clinical impact of the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GUO jiateng

Master of Clinical Medicine

Tongji Hospital

研究点 (1)

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