Intraoperative Paravertebral Block and Postoperative Complications (IPVB and POCs)

Tongji Hospital

Status: Enrolling

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

Treatments: Procedure: Paravertebral Block (PVB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07211529

TJ-JRB202508092 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Paravertebral Block (PVB)Group

Experimental group

Description:

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.

Treatment:

Procedure: Paravertebral Block (PVB)

Control Group

No Intervention group

Description:

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.