Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After VATS Lung Resection

Not Applicable

Recruiting

• Conditions: Vagus; Thoracoscopy; Pulmonary Resection; Postoperative Cough; Nerve Block

• Registration Number: NCT06500949
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Postoperative cough after pulmonary resection is a common issue seen after thoracic surgeries, hindering patients' recovery and affecting their postoperative quality of life. While vagus nerve pulmonary branch block has been known to reduce intraoperative coughing, its impact on postoperative cough post lung resection is uncertain. This study aims to assess the effects of vagus nerve pulmonary branch block on postoperative cough after VATS lung resection. A randomized controlled trial involving 104 thoracoscopic lung resection patients will assign them randomly to a vagus nerve pulmonary branch block group or a control group. The primary outcome measure is the postoperative cough incidence 3 weeks after lung resection. The secondary outcomes include assessing hoarseness in PACU, peak expiratory flow (PEF) on the first post-op day, NRS scores for cough, and LCQ-MC scores at 3 weeks post-surgery, as well as cough occurrence, NRS scores, and LCQ-MC scores at 8 weeks post-procedure.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study Start: 2024-07-15
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Age between 18 and 70 years old.
• BMI between 18 and 30 kilograms per square meter (kg/m²).
• ASA Physical Status Classification of I, II, or III.
• Preoperative pulmonary imaging demonstrating peripheral lesions, with clinical staging T≤2, N≤1, M0.
• Undergone thoracoscopic lung resection surgery.
• Patients managed by the same lead surgeon's team.
• Obtained informed consent, with patients agreeing and signing the informed consent document.

Exclusion Criteria

• Patients with a history of chemotherapy or previous pulmonary surgery.
• Presence of chronic cough due to respiratory infectious diseases, pharyngitis, rhinitis, COPD, asthma, post-nasal drip syndrome, etc.
• Individuals exhibiting ECG abnormalities such as atrial fibrillation, bundle branch block, frequent ventricular premature beats, pre-excitation syndrome, etc.
• Currently using ACE inhibitor medications.
• Presence of preoperative hoarseness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative cough following lung resection at 3 weeks post-operation	at 3 weeks post-operation	The incidence of post-lung resection cough was assessed at 3 weeks postoperatively.

Secondary Outcome Measures

Name	Time	Method
Peak expiratory flow rate on postoperative day 1	on postoperative day 1	Measurement of peak expiratory flow on postoperative day 1
Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operation	at 3 weeks post-operation	The LCQ-MC score ranges from a minimum of 0 to a maximum of 21, with three dimensions: physical, psychological, and social. Each dimension is scored from 1 to 7, and the total score is the sum of the three dimensions.Higher scores on the LCQ-MC indicate better health-related quality of life. A score of 0 represents the worst possible quality of life, while a score of 21 represents the best possible quality of life in relation to cough.
Condition of hoarseness in PACU	during in PACU, an average of 1 hour	Assessment of hoarseness in PACU following surgery
Numerical Rating Scale for cough intensity at 3 weeks post-operation	at 3 weeks post-operation	The scale ranges from 0 to 10, with 0 indicating no cough and 10 representing the worst imaginable cough.Higher scores on the Numerical Rating Scale for cough intensity indicate a more severe cough condition.
Incidence of postoperative cough following lung resection at 8 weeks post-operation	at 8 weeks post-operation	The incidence of post-lung resection cough was assessed at 8 weeks postoperatively.
Leicester Cough Questionnaire for Measuring Chronic Cough at 8 weeks post-operation	at 8 weeks post-operation	The LCQ-MC score ranges from a minimum of 0 to a maximum of 21, with three dimensions: physical, psychological, and social. Each dimension is scored from 1 to 7, and the total score is the sum of the three dimensions.Higher scores on the LCQ-MC indicate better health-related quality of life. A score of 0 represents the worst possible quality of life, while a score of 21 represents the best possible quality of life in relation to cough.
Numerical Rating Scale for cough intensity at 8 weeks post-operation	at 8 weeks post-operation	The scale ranges from 0 to 10, with 0 indicating no cough and 10 representing the worst imaginable cough.Higher scores on the Numerical Rating Scale for cough intensity indicate a more severe cough condition.

Trial Locations

Locations (1)

Second affiliated Hospital School of Medicine,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China