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

NCT05922449 | Completed

• 1 other identifier: TREC2023-KY020
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postoperative Pulmonary Complications

Keywords

Postoperative pulmonary complications; Thoracic paravertebral block; Postoperative analgesia; Video-Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Arterial partial pressure of oxygen (PaO2)

  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)

  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)

  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

  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

  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)

Study Arms (2)

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.

Procedure: Thoracic Paravertebral Block

Control group (C group)

NO INTERVENTION

This group of patients did not undergo any nerve block procedures before general anesthesia.

Interventions

Thoracic Paravertebral Block PROCEDURE

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.

Paravertebral block group (PV group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Beijing Chest Hospital: collaborator

Study Sites (2)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

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Study Officials

• Guyan Wang

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Packet information is hidden in serially numbered, sealed and opaque envelopes for allocation hiding. Due to the different anesthesia methods implemented in this study, the operators cannot achieve the blind method. The outcome assessor and data statisticians are blinded to the group assignment. If a major adverse event occurs during perioperative period that poses a serious threat to the safety of the subject and the anesthesiologist or attending physician deems it necessary to know the subject's grouping, an authorized blind person may open an emergency blind letter, record the time, cause and name of the blind person, and immediately report it to the supervisory board.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel controlled trial

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 28, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)