Postoperative Pulmonary Complications Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chest Hospital, Capital Medical University | Beijing | Beijing |
China | Beijing tongren Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tongren Hospital | Beijing Chest Hospital |
China,
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* Note: There are 27 references in all — Click here to view all references
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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