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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05922449
Other study ID # TREC2023-KY020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date March 31, 2024

Study information

Verified date March 2023
Source Beijing Tongren Hospital
Contact Jiayu Zhu
Phone 0086-15735178081
Email 2661106448@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 302
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms

  • Postoperative Pulmonary Complications

Intervention

Procedure:
Thoracic Paravertebral Block
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.

Locations

Country Name City State
China Beijing Chest Hospital, Capital Medical University Beijing Beijing
China Beijing tongren Hospital, Capital Medical University Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Beijing Tongren Hospital Beijing Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (27)

Bayman 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. — View Citation

Ben Aziz M, Mukhdomi J. Thoracic Paravertebral Block. 2023 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570560/ — View Citation

Bendixen 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 Onc — View Citation

Brassard CL, Lohser J, Donati F, Bussieres JS. Step-by-step clinical management of one-lung ventilation: continuing professional development. Can J Anaesth. 2014 Dec;61(12):1103-21. doi: 10.1007/s12630-014-0246-2. Epub 2014 Nov 12. English, French. — View Citation

Casati A, Alessandrini P, Nuzzi M, Tosi M, Iotti E, Ampollini L, Bobbio A, Rossini E, Fanelli G. A prospective, randomized, blinded comparison between continuous thoracic paravertebral and epidural infusion of 0.2% ropivacaine after lung resection surgery — View Citation

Chu 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/s12871-020-00 — View Citation

Colquhoun 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 Ventila — View Citation

de 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 co — View Citation

El-Tahan MR. Role of Thoracic Epidural Analgesia for Thoracic Surgery and Its Perioperative Effects. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1417-1426. doi: 10.1053/j.jvca.2016.09.010. Epub 2016 Sep 13. No abstract available. — View Citation

Falcoz 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 can — View Citation

Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal — View Citation

Jung DM, Ahn HJ, Jung SH, Yang M, Kim JA, Shin SM, Jeon S. Apneic oxygen insufflation decreases the incidence of hypoxemia during one-lung ventilation in open and thoracoscopic pulmonary lobectomy: A randomized controlled trial. J Thorac Cardiovasc Surg. — View Citation

Kang 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 — View Citation

Kaufmann KB, Loop T, Heinrich S; Working Group of the German Thorax Registry. Risk factors for post-operative pulmonary complications in lung cancer patients after video-assisted thoracoscopic lung resection: Results of the German Thorax Registry. Acta An — View Citation

Kimura 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. 202 — View Citation

Lederman 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. — View Citation

Li XF, Hu JR, Wu Y, Chen Y, Zhang MQ, Yu H. Comparative Effect of Propofol and Volatile Anesthetics on Postoperative Pulmonary Complications After Lung Resection Surgery: A Randomized Clinical Trial. Anesth Analg. 2021 Oct 1;133(4):949-957. doi: 10.1213/A — View Citation

Liang XL, An R, Chen Q, Liu HL. The Analgesic Effects of Thoracic Paravertebral Block versus Thoracic Epidural Anesthesia After Thoracoscopic Surgery: A Meta-Analysis. J Pain Res. 2021 Mar 26;14:815-825. doi: 10.2147/JPR.S299595. eCollection 2021. — View Citation

Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thora — View Citation

Lohser 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. — View Citation

Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S01 — View Citation

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. — View Citation

Tong 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.2022.110 — View Citation

Tong 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. — View Citation

Wang ML, Hung MH, Chen JS, Hsu HH, Cheng YJ. Nasal high-flow oxygen therapy improves arterial oxygenation during one-lung ventilation in non-intubated thoracoscopic surgery. Eur J Cardiothorac Surg. 2018 May 1;53(5):1001-1006. doi: 10.1093/ejcts/ezx450. — View Citation

Wu Z, Fang S, Wang Q, Wu C, Zhan T, Wu M. Patient-Controlled Paravertebral Block for Video-Assisted Thoracic Surgery: A Randomized Trial. Ann Thorac Surg. 2018 Sep;106(3):888-894. doi: 10.1016/j.athoracsur.2018.04.036. Epub 2018 May 12. — View Citation

Yeung 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. — View Citation

* Note: There are 27 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Within the first 7 days after operation
Secondary Arterial partial pressure of oxygen (PaO2) Unit: mmHg 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)
Secondary Arterial carbon dioxide pressure (PaCO2) Unit: mmHg 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)
Secondary Oxygenation index (OI) OI =PaO2/Inspired oxygen fraction (FiO2), Unit: mmHg 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)
Secondary Arterial blood pH Unitless 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)
Secondary Concentration of arterial blood lactate Unit: mmol/L 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)
Secondary Heart rate Unit: beats per minute 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)
Secondary Invasive arterial blood pressure Unit: mmHg 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)
Secondary Transcutaneous oxygen saturation (SpO2) Unit: %; This value is a percentage 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)
Secondary 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).
Preoperative; Postoperative day1; Postoperative day 2
Secondary 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. Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
Secondary Patient's postoperative consumption of sufentanil Provided through patient controlled intravenous analgesia (PCIA) equipment; Unit: mcg. Within 48 hours after operation
Secondary The incidence of opioid-related adverse effects Unit: %; This value is a percentage. Opioid-related adverse effects include nausea, vomiting, dizziness, pruritus. Within 48 hours after operation
Secondary 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). Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
Secondary 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. Within the first 7 days after surgery; 1 and 3 months after operation
Secondary 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. Within the first 7 days after surgery; 1 and 3 months after operation
Secondary Postoperative mortality rate Unit: %; This value is a percentage. 1 and 3 months after operation
Secondary Unplanned ICU hospitalization rate Unit: %; This value is a percentage. 1 months after operation
Secondary Unplanned ICU hospitalization duration Unit: Hour. 1 months after operation
Secondary Postoperative length of stay Unit: Day. from date of operation till date of discharge 1 months after operation
Secondary Hospitalization expense Unit: CNY. 1 months after operation
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