Using Thoracic Paravertebral Block for Perioperative Lung Preservation During VATS Pulmonary Surgery

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922449
• Other study ID #: TREC2023-KY020
• Status: Recruiting
• Phase: N/A
• 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
• 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

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)

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* Note: There are 27 references in all — Click 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