- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922449
Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiayu Zhu
- Phone Number: 0086-15735178081
- Email: 2661106448@qq.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100000
- Recruiting
- Beijing Tongren Hospital, Capital Medical University
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Contact:
- Jiayu Zhu
- Phone Number: 0086-15735178081
- Email: 2661106448@qq.com
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Beijing, Beijing, China, 100000
- Recruiting
- Beijing Chest Hospital, Capital Medical University
-
Contact:
- Biyu Wei
- Phone Number: 0086-18834184560
- Email: weibiyu11@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paravertebral block group (PV group)
This group of patients will undergo ultrasound-guided thoracic paravertebral nerve block in T4 and T7 thoracic paravertebral spaces before general anesthesia.
|
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.
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No Intervention: Control group (C group)
This group of patients did not undergo any nerve block procedures before general anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Within the first 7 days after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Unit: mmHg
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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)
|
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)
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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)
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OI =PaO2/Inspired oxygen fraction (FiO2), Unit: mmHg
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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)
|
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)
|
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)
|
Unit: mmol/L
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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)
|
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)
|
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)
|
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)
|
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)
|
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)
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Lung Ultrasound Score (LUS)
Time Frame: Preoperative; Postoperative day1; Postoperative day 2
|
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
|
Numerical rating scale (NRS)
Time Frame: Preoperative; Postoperative day1; Postoperative day 2; 1 and 3 months after operation
|
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
|
Patient's postoperative consumption of sufentanil
Time Frame: Within 48 hours after operation
|
Provided through patient controlled intravenous analgesia (PCIA) equipment; Unit: mcg.
|
Within 48 hours after operation
|
The incidence of opioid-related adverse effects
Time Frame: Within 48 hours after operation
|
Unit: %; This value is a percentage.
Opioid-related adverse effects include nausea, vomiting, dizziness, pruritus.
|
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
|
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
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The incidence of various postoperative pulmonary complications
Time Frame: Within the first 7 days after surgery; 1 and 3 months after operation
|
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
|
The incidence of various postoperative extrapulmonary complications
Time Frame: Within the first 7 days after surgery; 1 and 3 months after operation
|
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.
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Within the first 7 days after surgery; 1 and 3 months after operation
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Postoperative mortality rate
Time Frame: 1 and 3 months after operation
|
Unit: %; This value is a percentage.
|
1 and 3 months after operation
|
Unplanned ICU hospitalization rate
Time Frame: 1 months after operation
|
Unit: %; This value is a percentage.
|
1 months after operation
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Unplanned ICU hospitalization duration
Time Frame: 1 months after operation
|
Unit: Hour.
|
1 months after operation
|
Postoperative length of stay
Time Frame: 1 months after operation
|
Unit: Day. from date of operation till date of discharge
|
1 months after operation
|
Hospitalization expense
Time Frame: 1 months after operation
|
Unit: CNY.
|
1 months after operation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: guyan Wang, Beijing Tongren Hospital
Publications and helpful links
General Publications
- 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 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.
- 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 Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.
- 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 comparing intravenous and inhalational anaesthesia. Br J Anaesth. 2017 Oct 1;119(4):655-663. doi: 10.1093/bja/aex230.
- 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 Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048.
- 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.
- 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.
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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/
- 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: 10.1186/s12957-020-02071-8.
- 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/s12871-020-00976-1.
- 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.2022.110770. Epub 2022 Mar 22.
- 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. 2021 Jul 1;133(1):44-52. doi: 10.1213/ANE.0000000000005375.
- 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.
- 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 Anaesthesiol Scand. 2019 Sep;63(8):1009-1018. doi: 10.1111/aas.13388. Epub 2019 May 29.
- 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.
- 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. 2017 Jul;154(1):360-366. doi: 10.1016/j.jtcvs.2017.02.054. Epub 2017 Mar 10.
- 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.
- 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/ANE.0000000000005334.
- 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-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
- 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.
- 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/S0140-6736(02)08266-1.
- 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.
- 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. Eur J Anaesthesiol. 2006 Dec;23(12):999-1004. doi: 10.1017/S0265021506001104. Epub 2006 Jul 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TREC2023-KY020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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