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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracoscopy; Nerve Block; Pulmonary Resection; Postoperative Cough; Vagus
• Intervention / Treatment: Procedure: Vagus Nerve Pulmonary Branch Block; Procedure: Vagus Nerve Pulmonary Branch Injection

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Yu, doctor; Phone Number: +8613958033387; Email: zryulina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second affiliated Hospital School of Medicine,Zhejiang University
      • Contact: Lina Yu, doctor; Phone Number: +8613958033387; Email: zryulina@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vagus nerve pulmonary branch block group (V group); After thoracotomy, under direct thoracoscopic visualization, 2.5 ml of 0.375% ropivacaine was injected in proximity to the main trunk of the pulmonary branches of the vagus nerve.	Procedure: Vagus Nerve Pulmonary Branch Block; Following thoracotomy, the thoracic surgeon, under direct thoracoscopic guidance, used forceps to elevate the apex of the lung, thus exposing the main trunk of the pulmonary branches of the vagus nerve. The injection needle was then advanced from a lateral-to-medial direction, and 2.5 ml of 0.375% ropivacaine was administered in close proximity to the targeted vagal branch.
Placebo Comparator: Control group (C group); After thoracotomy, under direct thoracoscopic visualization, 2.5 ml of normal saline was administered in the vicinity of the principal trunk of the pulmonary branches of the vagus nerve.	Procedure: Vagus Nerve Pulmonary Branch Injection; Following thoracotomy, the thoracic surgeon, under direct thoracoscopic guidance, used forceps to elevate the apex of the lung, thus exposing the main trunk of the pulmonary branches of the vagus nerve. The injection needle was then advanced from a lateral-to-medial direction, and 2.5 ml of normal saline was administered in close proximity to the targeted vagal branch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative cough following lung resection at 3 weeks post-operation	The incidence of post-lung resection cough was assessed at 3 weeks postoperatively.	at 3 weeks post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condition of hoarseness in PACU	Assessment of hoarseness in PACU following surgery	during in PACU, an average of 1 hour
Peak expiratory flow rate on postoperative day 1	Measurement of peak expiratory flow on postoperative day 1	on postoperative day 1
Incidence of postoperative cough following lung resection at 8 weeks post-operation	The incidence of post-lung resection cough was assessed at 8 weeks postoperatively.	at 8 weeks post-operation
Numerical Rating Scale for cough intensity 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.	at 3 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough 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.	at 3 weeks post-operation
Numerical Rating Scale for cough intensity 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.	at 8 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough 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.	at 8 weeks post-operation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Vagus; Chronic cough; Postoperative cough; Thoracoscopy or Video-assisted thoracoscopic surgery; Pulmonary resection or Lung resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 2024-0618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No