Clinical trial NCT06500949: Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After VATS Lung Resection
Official title: Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After Thoracoscopic Lung Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Cough
Thoracoscopy
Pulmonary Resection
Vagus
Nerve Block
Keywords: Chronic cough
Postoperative cough
Thoracoscopy or Video-assisted thoracoscopic surgery
Pulmonary resection or Lung resection
Vagus
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative cough following lung resection at 3 weeks post-operation
timeFrame: at 3 weeks post-operation
Secondary outcomes:
measure: Condition of hoarseness in PACU
timeFrame: during in PACU, an average of 1 hour
measure: Peak expiratory flow rate on postoperative day 1
timeFrame: on postoperative day 1
measure: Numerical Rating Scale for cough intensity at 3 weeks post-operation
timeFrame: at 3 weeks post-operation
measure: Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operation
timeFrame: at 3 weeks post-operation
measure: Incidence of postoperative cough following lung resection at 8 weeks post-operation
timeFrame: at 8 weeks post-operation
measure: Numerical Rating Scale for cough intensity at 8 weeks post-operation
timeFrame: at 8 weeks post-operation
measure: Leicester Cough Questionnaire for Measuring Chronic Cough at 8 weeks post-operation
timeFrame: at 8 weeks post-operation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated Hospital School of Medicine,Zhejiang University
state: Zhejiang
Study officials:
References: