Postoperative Pulmonary ComplicationsNCT05922449
Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery
A study testing Thoracic Paravertebral Block in people with Postoperative Pulmonary Complications, run by Beijing Tongren Hospital at 2 sites in China.
Trial summary
Background: Postoperative pulmonary complications (PPCs) may extend the length of stay of patients and even increase perioperative mortality after video-assisted thoracoscopic (VATS) pulmonary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications
- What is being tested?
- Thoracic Paravertebral Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective VATS lobectomy/segmentectomy had an expected operation duration (from skin incision to suture) greater than 1h
- Age>18
- American society of Anesthesiologists (ASA) physical status classification system: I - III
Who cannot join
- Patients with acute or chronic respiratory failure, chronic obstructive pulmonary disease (GOLD) grade ≥ Grade III, poorly controlled asthma or acute respiratory distress syndrome (ARDS, according to the new definition of ARDS at the 2011 Berlin Conference)
- Patients with severe cardiovascular complications (defined as New York Heart Association (NYHA) Grade IV, acute coronary syndrome, or persistent ventricular tachycardia)
- Patients who had a history of ipsilateral thoracotomy or had a history of mechanical ventilation within 4 weeks
- Patients with contraindications to TPVB (coagulation dysfunction, anticoagulation or antiplatelet therapy, skin ulcer infection, local anesthetic allergy, Spinal deformity, etc.)
- Patients with trachea malformation or tracheotomy
- Pregnant or lactating patients
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Beijing tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery: A Dual Center Randomized Controlled Trial
Background: Postoperative pulmonary complications (PPCs) may extend the length of stay of patients and even increase perioperative mortality after video-assisted thoracoscopic (VATS) pulmonary surgery. Thoracic paravertebral block (TPVB) can provide effective analgesia after VATS, however little is known about the effect of TPVB on PPCs. This study aims to determine whether TPVB combined with general anesthesia results in reducing PPCs and achieve perioperative lung protection in VATS pulmonary surgery compared with simple general anesthesia.
Methods: A total of 302 patients undergoing VATS lobectomy/segmentectomy will be randomly divided into two groups: Paravertebral block group (PV group) and Control group (C group). Patients of PV group will receive thoracic paravertebral block: 15 ml of 0.5% ropivacaine will be administered to the T4 and T7 thoracic paravertebral spaces respectively before general anesthesia. Patients of C group will not undergo intervention. Both groups of patients adopted protective ventilation strategy during operation. Perioperative protective mechanical ventilation and standard fluid management will be applied in both groups. Patient controlled intravenous analgesia was used for postoperative analgesia. The primary endpoint is the composite outcome of PPCs within 7 days after surgery. Secondary end points include blood gas analysis, postoperative lung ultrasound score, NRS score, QoR-15 score, hospitalization related indicators and long-term prognosis indicators.
Read the detailed description
Surgical resection is still the go-to treatment for lung cancer, which is the leading cause of cancer death As a minimally invasive operation, video-assisted thoracoscopic surgery (VATS) has significantly reduced surgical trauma and systemic inflammation, and has become the standard treatment method for lung cancer.
Postoperative pulmonary complications (PPCs) are one of the most common complications after thoracoscopic lung cancer surgery, with an incidence of 40.8%. PPCs increase hospitalization time, hospitalization cost, and perioperative mortality, and affect the treatment effect and utilization of medical resources. One of the most pressing clinical issues is how to lower the prevalence of PPCs. Previous research has shown that lung protective ventilation strategies, including low tidal volume, positive end expiratory pressure (PEEP), low inhalation oxygen concentration, etc., have a good prognosis in patients with lung injury, but they may not fully prevent acute lung injury caused by one-lung ventilation (OLV) during VATS.
The incidence of pain 24 hours after VATS was 38%, and the incidence of chronic pain 6 months after VATS was 25%. Poor postoperative analgesia will affect postoperative recovery, which may raise the risk of pulmonary complications due to insufficient respiratory function and weak sputum excretion. Thus, it is crucial to effectively control acute discomfort following VATS.
Ultrasound guided thoracic paravertebral block (TPVB) is a commonly used regional block technique in thoracic surgery. Local anesthetics can be injected into the paravertebral space to block the ipsilateral sympathetic and somatosensory nerves. TPVB combined with general anesthesia (GA) can reduce the pain after VATS, decreases the expression of matrix metalloproteinase-9, reduce the inflammatory reaction after thoracic surgery, improve the postoperative survival rate by blocking the unilateral sympathetic nerve, improve the postoperative rehabilitation of patients after VATS lung cancer radical surgery, and reduce the postoperative tumor recurrence. According to a recent retrospective propensity matching analysis, TPVB and GA together were linked to a decreased incidence of PPCs (29.8% vs. 34.2%). However, a prospective study on the effects of GA combined with GA alone vs GA coupled with TPVB on PPCs following VATS pulmonary surgery has not been retrieved.
The aim of this study is designed to explore whether general anesthesia combined with thoracic paravertebral block can reduce atelectasis, lung inflammation, and lung injury compared to general anesthesia during VATS pulmonary surgery, thereby reducing the incidence of postoperative pulmonary complications, achieving lung protection, and improving long-term prognosis of patients.
- Conditions
- Postoperative Pulmonary Complications
- Being tested
- Thoracic Paravertebral Block
- Keywords
- Postoperative pulmonary complications, Thoracic paravertebral block, Postoperative analgesia, Video-Assisted Thoracoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Paravertebral BlockProcedure or surgery
Patients randomly assigned to PV group will be placed in lateral position, and punctured using the out of plane technique guided by ultrasound (Shenzhen Huasheng Navi low-frequency convex array probe). 15 ml of 0.5% ropivacaine was administered to the T4 and T7 thoracic paravertebral spaces respectively, for a total of 30 ml. After injection, the pleura of the punctured segment and adjacent segments could be obviously moved down. Upon successful puncture, the patient was transferred to the supine position. After 5, 10, and 15 minutes, the range of sensory blockage was tested at T3~T8 to cover the surgical area.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block group (PV group) | Experimental | This group of patients will undergo ultrasound-guided thoracic paravertebral nerve block in T4 and T7 thoracic paravertebral spaces before general anesthesia. Receives: Procedure: Thoracic Paravertebral Block |
| Control group (C group) | No intervention | This group of patients did not undergo any nerve block procedures before general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the composite of postoperative pulmonary complications (PPCs) within 7 days after surgery
Unit: %; This value is a percentage. Patients with at least one complication were considered eligible for the primary end points.
Postoperative pulmonary complications include pneumonia; aspiration pneumonitis; atelectasis; respiratory failure; bronchospasm; pulmonary congestion; pleural effusion; pneumothorax.
Measured: Within the first 7 days after operation
Secondary outcomes (20)
Arterial partial pressure of oxygen (PaO2)
Unit: mmHg
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Arterial carbon dioxide pressure (PaCO2)
Unit: mmHg
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Oxygenation index (OI)
OI =PaO2/Inspired oxygen fraction (FiO2), Unit: mmHg
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Arterial blood pH
Unitless
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Concentration of arterial blood lactate
Unit: mmol/L
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Heart rate
Unit: beats per minute
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Invasive arterial blood pressure
Unit: mmHg
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Transcutaneous oxygen saturation (SpO2)
Unit: %; This value is a percentage
Measured: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Lung Ultrasound Score (LUS)
Unit: point Operation method: Each side of the chest of the patient was divided into six regions with the front axillary line, the posterior axillary line, and the nipple line as the boundary. Use the ultrasonic probe to scan each area from right to left, from top to bottom, and from front to back.
LUS score = sum of all 12 regions, Min = 0; Max = 36. The higher the score, the worse the degree of ventilation is considered.
Score according to the number of B lines in the LUS image of each area. 0: B lines ≤ 2; 1 point: > 2 well-spaced B-lines; 2 points: Multiple coalescent B lines; 3 points: white lung (lung consolidation).
Measured: Preoperative; Postoperative day1; Postoperative day 2
Numerical rating scale (NRS)
Unit: point, including chest NRS score for rest and cough. Participants were asked to rate their average pain intensity for rest and cough by selecting a single number from 0 to 10. The end-point descriptors for the NRS was "No pain"(0) to "The most intense pain imaginable" (10). The higher the score, the more severe the pain situation.
Measured: Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
Patient's postoperative consumption of sufentanil
Provided through patient controlled intravenous analgesia (PCIA) equipment; Unit: mcg.
Measured: Within 48 hours after operation
The incidence of opioid-related adverse effects
Unit: %; This value is a percentage. Opioid-related adverse effects include nausea, vomiting, dizziness, pruritus.
Measured: Within 48 hours after operation
Quality of recovery with the 15-item (QoR-15)
Unit: point. QoR-15 is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).
Measured: Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
The incidence of various postoperative pulmonary complications
Unit: %; This value is a percentage. Postoperative pulmonary complications include pneumonia; aspiration pneumonitis; atelectasis; respiratory failure; bronchospasm; pulmonary congestion; pleural effusion; pneumothorax.
Measured: Within the first 7 days after surgery; 1 and 3 months after operation
The incidence of various postoperative extrapulmonary complications
Unit: %; This value is a percentage. Postoperative pulmonary complications include arrhythmia; cardiovascular complications (arrhythmias, acute coronary syndrome, mycardial infarction, acute congestive heart failure); cerebrovascular complications (cerebral infarction, cerebral hemorrhage); postoperative cognitive dysfunction (POCD); postoperative renal complications; shock; postoperative extrapulmonary infection.
Measured: Within the first 7 days after surgery; 1 and 3 months after operation
Postoperative mortality rate
Unit: %; This value is a percentage.
Measured: 1 and 3 months after operation
Unplanned ICU hospitalization rate
Unit: %; This value is a percentage.
Measured: 1 months after operation
Unplanned ICU hospitalization duration
Unit: Hour.
Measured: 1 months after operation
Postoperative length of stay
Unit: Day. from date of operation till date of discharge
Measured: 1 months after operation
Hospitalization expense
Unit: CNY.
Measured: 1 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Randomized parallel controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922449
- Sponsor's protocol ID
- TREC2023-KY020
- Status last verified
- Mar 2023
- First submitted
- 1 Jun 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hurtgen M, Petersen RH, Hansen H, Brunelli A; ESTS Database Committee and ESTS Minimally Invasive Interest Group. Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):602-9. doi: 10.1093/ejcts/ezv154. Epub 2015 Apr 26.
PubMed 25913824Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808.
PubMed 26197368Colquhoun DA, Leis AM, Shanks AM, Mathis MR, Naik BI, Durieux ME, Kheterpal S, Pace NL, Popescu WM, Schonberger RB, Kozower BD, Walters DM, Blasberg JD, Chang AC, Aziz MF, Harukuni I, Tieu BH, Blank RS. A Lower Tidal Volume Regimen during One-lung Ventilation for Lung Resection Surgery Is Not Associated with Reduced Postoperative Pulmonary Complications. Anesthesiology. 2021 Apr 1;134(4):562-576. doi: 10.1097/ALN.0000000000003729.
PubMed 33635945Lederman D, Easwar J, Feldman J, Shapiro V. Anesthetic considerations for lung resection: preoperative assessment, intraoperative challenges and postoperative analgesia. Ann Transl Med. 2019 Aug;7(15):356. doi: 10.21037/atm.2019.03.67.
PubMed 31516902Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.
PubMed 27160473Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.
PubMed 28248713Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642Tong C, Zhu H, Li B, Wu J, Xu M. Impact of paravertebral blockade use in geriatric patients undergoing thoracic surgery on postoperative adverse outcomes. J Thorac Dis. 2019 Dec;11(12):5169-5176. doi: 10.21037/jtd.2019.12.13.
PubMed 32030234Ben Aziz M, Mukhdomi J. Thoracic Paravertebral Block. 2026 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570560/
PubMed 34033322Kang K, Meng X, Li B, Yuan J, Tian E, Zhang J, Zhang W. Effect of thoracic paravertebral nerve block on the early postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery. World J Surg Oncol. 2020 Nov 12;18(1):298. doi: 10.1186/s12957-020-02071-8.
PubMed 33183325Chu H, Dong H, Wang Y, Niu Z. Effects of ultrasound-guided paravertebral block on MMP-9 and postoperative pain in patients undergoing VATS lobectomy: a randomized, controlled clinical trial. BMC Anesthesiol. 2020 Mar 6;20(1):59. doi: 10.1186/s12871-020-00976-1.
PubMed 32143570Tong C, Zheng J, Wu J. The effects of paravertebral blockade usage on pulmonary complications, atrial fibrillation and length of hospital stay following thoracoscopic lung cancer surgery. J Clin Anesth. 2022 Aug;79:110770. doi: 10.1016/j.jclinane.2022.110770. Epub 2022 Mar 22.
PubMed 35334289Kimura A, Suehiro K, Juri T, Fujimoto Y, Yoshida H, Tanaka K, Mori T, Nishikawa K. Hemodynamic Changes via the Lung Recruitment Maneuver Can Predict Fluid Responsiveness in Stroke Volume and Arterial Pressure During One-Lung Ventilation. Anesth Analg. 2021 Jul 1;133(1):44-52. doi: 10.1213/ANE.0000000000005375.
PubMed 33687175de la Gala F, Pineiro P, Reyes A, Vara E, Olmedilla L, Cruz P, Garutti I. Postoperative pulmonary complications, pulmonary and systemic inflammatory responses after lung resection surgery with prolonged one-lung ventilation. Randomized controlled trial comparing intravenous and inhalational anaesthesia. Br J Anaesth. 2017 Oct 1;119(4):655-663. doi: 10.1093/bja/aex230.
PubMed 29121283
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery: A Dual Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05922449
- Acronym / sponsor ID
- TREC2023-KY020
- Conditions
- Postoperative Pulmonary Complications
- Keywords
- Postoperative pulmonary complications, Thoracic paravertebral block, Postoperative analgesia, Video-Assisted Thoracoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Beijing Chest Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Jun 2023 (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.
Background: Postoperative pulmonary complications (PPCs) may extend the length of stay of patients and even increase perioperative mortality after video-assisted thoracoscopic (VATS) pulmonary surgery. Thoracic paravertebral block (TPVB) can provide effective analgesia after VATS, however little is known about the effect of TPVB on PPCs. This study aims to determine whether TPVB combined with general anesthesia results in reducing PPCs and achieve perioperative lung protection in VATS pulmonary surgery compared with simple general anesthesia.
Methods: A total of 302 patients undergoing VATS lobectomy/segmentectomy will be randomly divided into two groups: Paravertebral block group (PV group) and Control group (C group). Patients of PV group will receive thoracic paravertebral block: 15 ml of 0.5% ropivacaine will be administered to the T4 and T7 thoracic paravertebral spaces respectively before general anesthesia. Patients of C group will not undergo intervention. Both groups of patients adopted protective ventilation strategy during operation. Perioperative protective mechanical ventilation and standard fluid management will be applied in both groups. Patient controlled intravenous analgesia was used for postoperative analgesia. The primary endpoint is the composite outcome of PPCs within 7 days after surgery. Secondary end points include blood gas analysis, postoperative lung ultrasound score, NRS score, QoR-15 score, hospitalization related indicators and long-term prognosis indicators.
Detailed description
Surgical resection is still the go-to treatment for lung cancer, which is the leading cause of cancer death As a minimally invasive operation, video-assisted thoracoscopic surgery (VATS) has significantly reduced surgical trauma and systemic inflammation, and has become the standard treatment method for lung cancer.
Postoperative pulmonary complications (PPCs) are one of the most common complications after thoracoscopic lung cancer surgery, with an incidence of 40.8%. PPCs increase hospitalization time, hospitalization cost, and perioperative mortality, and affect the treatment effect and utilization of medical resources. One of the most pressing clinical issues is how to lower the prevalence of PPCs. Previous research has shown that lung protective ventilation strategies, including low tidal volume, positive end expiratory pressure (PEEP), low inhalation oxygen concentration, etc., have a good prognosis in patients with lung injury, but they may not fully prevent acute lung injury caused by one-lung ventilation (OLV) during VATS.
The incidence of pain 24 hours after VATS was 38%, and the incidence of chronic pain 6 months after VATS was 25%. Poor postoperative analgesia will affect postoperative recovery, which may raise the risk of pulmonary complications due to insufficient respiratory function and weak sputum excretion. Thus, it is crucial to effectively control acute discomfort following VATS.
Ultrasound guided thoracic paravertebral block (TPVB) is a commonly used regional block technique in thoracic surgery. Local anesthetics can be injected into the paravertebral space to block the ipsilateral sympathetic and somatosensory nerves. TPVB combined with general anesthesia (GA) can reduce the pain after VATS, decreases the expression of matrix metalloproteinase-9, reduce the inflammatory reaction after thoracic surgery, improve the postoperative survival rate by blocking the unilateral sympathetic nerve, improve the postoperative rehabilitation of patients after VATS lung cancer radical surgery, and reduce the postoperative tumor recurrence. According to a recent retrospective propensity matching analysis, TPVB and GA together were linked to a decreased incidence of PPCs (29.8% vs. 34.2%). However, a prospective study on the effects of GA combined with GA alone vs GA coupled with TPVB on PPCs following VATS pulmonary surgery has not been retrieved.
The aim of this study is designed to explore whether general anesthesia combined with thoracic paravertebral block can reduce atelectasis, lung inflammation, and lung injury compared to general anesthesia during VATS pulmonary surgery, thereby reducing the incidence of postoperative pulmonary complications, achieving lung protection, and improving long-term prognosis of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel controlled trial
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block group (PV group) | Experimental | Procedure: Thoracic Paravertebral BlockThis group of patients will undergo ultrasound-guided thoracic paravertebral nerve block in T4 and T7 thoracic paravertebral spaces before general anesthesia. |
| Control group (C group) | No intervention | –This group of patients did not undergo any nerve block procedures before general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective VATS lobectomy/segmentectomy had an expected operation duration (from skin incision to suture) greater than 1h
- Age>18
- American society of Anesthesiologists (ASA) physical status classification system: I - III
Key exclusion criteria (6 listed)
- Patients with acute or chronic respiratory failure, chronic obstructive pulmonary disease (GOLD) grade ≥ Grade III, poorly controlled asthma or acute respiratory distress syndrome (ARDS, according to the new definition of ARDS at the 2011 Berlin Conference)
- Patients with severe cardiovascular complications (defined as New York Heart Association (NYHA) Grade IV, acute coronary syndrome, or persistent ventricular tachycardia)
- Patients who had a history of ipsilateral thoracotomy or had a history of mechanical ventilation within 4 weeks
- Patients with contraindications to TPVB (coagulation dysfunction, anticoagulation or antiplatelet therapy, skin ulcer infection, local anesthetic allergy, Spinal deformity, etc.)
- Patients with trachea malformation or tracheotomy
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 |
|---|---|---|
| Thoracic Paravertebral BlockPatients randomly assigned to PV group will be placed in lateral position, and punctured using the out of plane technique guided by ultrasound (Shenzhen Huasheng Navi low-frequency convex array probe). 15 ml of 0.5% ropivacaine was administered to the T4 and T7 thoracic paravertebral spaces respectively, for a total of 30 ml. After injection, the pleura of the punctured segment and adjacent segments could be obviously moved down. Upon successful puncture, the patient was transferred to the supine position. After 5, 10, and 15 minutes, the range of sensory blockage was tested at T3~T8 to cover the surgical area. | Procedure or surgery | Paravertebral block group (PV group) |
Primary outcome
The incidence of the composite of postoperative pulmonary complications (PPCs) within 7 days after surgery
Time frame: Within the first 7 days after operation
Unit: %; This value is a percentage. Patients with at least one complication were considered eligible for the primary end points. Postoperative pulmonary complications include pneumonia; aspiration pneumonitis; atelectasis; respiratory failure; bronchospasm; pulmonary congestion; pleural effusion; pneumothorax.
20 secondary outcomes
Arterial partial pressure of oxygen (PaO2)
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Arterial carbon dioxide pressure (PaCO2)
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Oxygenation index (OI)
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Arterial blood pH
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Concentration of arterial blood lactate
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Heart rate
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Invasive arterial blood pressure
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Transcutaneous oxygen saturation (SpO2)
Time frame: Preoperative; one-lung ventilation (OLV) for 30 minutes; 5 minutes after the end of one lung ventilation; 30 minutes after entering the postoperative pulmonary complications (PACU)
Lung Ultrasound Score (LUS)
Time frame: Preoperative; Postoperative day1; Postoperative day 2
Numerical rating scale (NRS)
Time frame: Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
Patient's postoperative consumption of sufentanil
Time frame: Within 48 hours after operation
The incidence of opioid-related adverse effects
Time frame: Within 48 hours after operation
Quality of recovery with the 15-item (QoR-15)
Time frame: Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
The incidence of various postoperative pulmonary complications
Time frame: Within the first 7 days after surgery; 1 and 3 months after operation
The incidence of various postoperative extrapulmonary complications
Time frame: Within the first 7 days after surgery; 1 and 3 months after operation
Postoperative mortality rate
Time frame: 1 and 3 months after operation
Unplanned ICU hospitalization rate
Time frame: 1 months after operation
Unplanned ICU hospitalization duration
Time frame: 1 months after operation
Postoperative length of stay
Time frame: 1 months after operation
Hospitalization expense
Time frame: 1 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 35020204Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
- Results publication: PubMed 25913824Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hurtgen M, Petersen RH, Hansen H, Brunelli A; ESTS Database Committee and ESTS Minimally Invasive Interest Group. Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):602-9. doi: 10.1093/ejcts/ezv154. Epub 2015 Apr 26.
- Results publication: PubMed 26197368Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808.
- Results publication: PubMed 33635945Colquhoun DA, Leis AM, Shanks AM, Mathis MR, Naik BI, Durieux ME, Kheterpal S, Pace NL, Popescu WM, Schonberger RB, Kozower BD, Walters DM, Blasberg JD, Chang AC, Aziz MF, Harukuni I, Tieu BH, Blank RS. A Lower Tidal Volume Regimen during One-lung Ventilation for Lung Resection Surgery Is Not Associated with Reduced Postoperative Pulmonary Complications. Anesthesiology. 2021 Apr 1;134(4):562-576. doi: 10.1097/ALN.0000000000003729.
- Results publication: PubMed 31516902Lederman D, Easwar J, Feldman J, Shapiro V. Anesthetic considerations for lung resection: preoperative assessment, intraoperative challenges and postoperative analgesia. Ann Transl Med. 2019 Aug;7(15):356. doi: 10.21037/atm.2019.03.67.
- Results publication: PubMed 27160473Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.
- Results publication: PubMed 28248713Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.
- Results publication: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
- Results publication: PubMed 32030234Tong C, Zhu H, Li B, Wu J, Xu M. Impact of paravertebral blockade use in geriatric patients undergoing thoracic surgery on postoperative adverse outcomes. J Thorac Dis. 2019 Dec;11(12):5169-5176. doi: 10.21037/jtd.2019.12.13.
- Results publication: PubMed 34033322Ben Aziz M, Mukhdomi J. Thoracic Paravertebral Block. 2026 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570560/
- Results publication: PubMed 33183325Kang K, Meng X, Li B, Yuan J, Tian E, Zhang J, Zhang W. Effect of thoracic paravertebral nerve block on the early postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery. World J Surg Oncol. 2020 Nov 12;18(1):298. doi: 10.1186/s12957-020-02071-8.
- Results publication: PubMed 32143570Chu H, Dong H, Wang Y, Niu Z. Effects of ultrasound-guided paravertebral block on MMP-9 and postoperative pain in patients undergoing VATS lobectomy: a randomized, controlled clinical trial. BMC Anesthesiol. 2020 Mar 6;20(1):59. doi: 10.1186/s12871-020-00976-1.
- 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. This study is not recruiting at the moment.
Guyan Wang study director
Beijing Tongren Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Paravertebral Block in people with Postoperative Pulmonary Complications, run by Beijing Tongren Hospital at 2 sites 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of the composite of postoperative pulmonary complications (PPCs) within 7 days after surgery (time frame: Within the first 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922449, which also lists 28 linked publications.
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 9 Aug 2024; AzTrials last refreshed its copy on 5 Nov 2026.