Intraoperative Paravertebral Block and Postoperative Complications

Not Applicable

Recruiting

• Conditions: Video-assisted Thoracoscopic Surgery (VATS); Lung Cancer (Diagnosis); Pulmonary Infections; Respiratory Failure Without Hypercapnia; Pleural Effusion Due to Another Disorder (Disorder); Atelectasis; Bronchospasm; Pneumothorax; Pulmonary Embolism (Diagnosis); Bronchopleural Fistula

• Registration Number: NCT07211529
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2025-03-25
• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2028-05-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Male or female participants aged 18 years or older.
2. 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.
3. Signed informed consent obtained prior to study participation. -

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	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.

Trial Locations

Locations (1)

Tongji Medical College of HUST: Huazhong University of Science and Technology Tongji Medical College Tongji Hospital; 🇨🇳 Wuhan, Hubei, China