Video-assisted Thoracoscopic Surgery (VATS)IPVB and POCsNCT07211529
Intraoperative Paravertebral Block and Postoperative Complications
A study testing Paravertebral Block (PVB) in people with Video-assisted Thoracoscopic Surgery (VATS) and Lung Cancer (Diagnosis), run by Tongji Hospital at 1 site in China.
Trial summary
This study aims to evaluate the clinical association between intraoperative paravertebral block and the reduction of postoperative complications following thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery (VATS), Lung Cancer (Diagnosis), Pulmonary Infections
- What is being tested?
- Paravertebral Block (PVB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Medical College of HUST: Huazhong University of Science and Technology Tongji Medical College Tongji Hospital
Wuhan, Hubei, 430000
Guo jiateng Guo, 18737552580, 18737552580@163.com
About this study
Official title: Perioperative Paravertebral Block Reduces Postoperative Complications in Thoracic Surgery: An Observational Study
This study aims to evaluate the clinical association between intraoperative paravertebral block and the reduction of postoperative complications following thoracic surgery.
Read the 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.
- Conditions
- Video-assisted Thoracoscopic Surgery (VATS), Lung Cancer (Diagnosis), Pulmonary Infections, Respiratory Failure Without Hypercapnia, Pleural Effusion Due to Another Disorder (Disorder), Atelectasis
- Being tested
- Paravertebral Block (PVB)
- Keywords
- Paravertebral Block (PVB), Video-Assisted Thoracoscopic Surgery (VATS), Postoperative Complications
- Medical subject headings
- Lung Neoplasms, Disease, Respiratory Insufficiency, Pulmonary Atelectasis, Bronchial Spasm, Pneumothorax, Pulmonary Embolism, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral Block (PVB)Procedure or surgery
Also called PVB, Paravertebral Analgesia, Paravertebral Injection, Ultrasound-Guided Paravertebral Block (UG-PVB / US-PVB)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start25 Mar 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic Surgery (VATS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUO jiateng, Tongji Hospital
- Investigators
- Zhang qin Zhang, Principal investigator, Huazhong keji daxue tongji yixue yuan fushu tongji yiyuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211529
- Sponsor's protocol ID
- TJ-JRB202508092
- Other IDs
- TJ-JRB202508092
- Acronym
- IPVB and POCs
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Paravertebral Block Reduces Postoperative Complications in Thoracic Surgery: An Observational Study
- ClinicalTrials.gov ID
- NCT07211529
- Acronym / sponsor ID
- IPVB and POCs / TJ-JRB202508092
- Conditions
- Video-assisted Thoracoscopic Surgery (VATS), Lung Cancer (Diagnosis), Pulmonary Infections, Respiratory Failure Without Hypercapnia, Pleural Effusion Due to Another Disorder (Disorder), Atelectasis
- Keywords
- Paravertebral Block (PVB), Video-Assisted Thoracoscopic Surgery (VATS), Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block (PVB)Group | Experimental | Procedure: Paravertebral Block (PVB)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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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. -
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral Block (PVB)Also: PVB, Paravertebral Analgesia, Paravertebral Injection, Ultrasound-Guided Paravertebral Block (UG-PVB / US-PVB)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 or surgery | Paravertebral Block (PVB)Group |
Primary outcome
Postoperative Complications
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhang qin Zhang principal investigator
Huazhong keji daxue tongji yixue yuan fushu tongji yiyuan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral Block (PVB) in people with Video-assisted Thoracoscopic Surgery (VATS) and Lung Cancer (Diagnosis), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo jiateng Guo (18737552580, 18737552580@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications (time frame: 1 to 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.