Intraoperative Paravertebral Block and Postoperative Complications

NCT07211529 | Recruiting

• 1 other identifier: TJ-JRB202508092
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

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; Acute Respiratory Distress Syndrome (ARDS)

Keywords

Paravertebral Block (PVB); Video-Assisted Thoracoscopic Surgery (VATS); Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications

  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.

  1 to 3 months postoperatively

Study Arms (2)

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.

Procedure: Paravertebral Block (PVB)

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.

Interventions

Paravertebral Block (PVB) PROCEDURE

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.

Also known as: PVB, Paravertebral Analgesia, Paravertebral Injection, Ultrasound-Guided Paravertebral Block (UG-PVB / US-PVB), Thoracic Paravertebral Block (TPVB), Paravertebral Nerve Block

Paravertebral Block (PVB)Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Medical College of HUST: Huazhong University of Science and Technology Tongji Medical College Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease; Respiratory Insufficiency; Pulmonary Atelectasis; Bronchial Spasm; Pneumothorax; Pulmonary Embolism; Respiratory Distress Syndrome; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Bronchial Diseases; Pleural Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhang qin Zhang

  Huazhong keji daxue tongji yixue yuan fushu tongji yiyuan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo jiateng Guo

CONTACT

18737552580; 18737552580@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Clinical Medicine

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)