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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06500949
Enrollment
104
Registered
2024-07-15
Start date
2024-07-15
Completion date
2025-07-31
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Block, Postoperative Cough, Pulmonary Resection, Thoracoscopy, Vagus

Keywords

Chronic cough, Postoperative cough, Thoracoscopy or Video-assisted thoracoscopic surgery, Pulmonary resection or Lung resection, Vagus

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.

Interventions

PROCEDUREVagus 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.

PROCEDUREVagus 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative cough following lung resection at 3 weeks post-operationat 3 weeks post-operationThe incidence of post-lung resection cough was assessed at 3 weeks postoperatively.

Secondary

MeasureTime frameDescription
Peak expiratory flow rate on postoperative day 1on postoperative day 1Measurement of peak expiratory flow on postoperative day 1
Numerical Rating Scale for cough intensity at 3 weeks post-operationat 3 weeks post-operationThe 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.
Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operationat 3 weeks post-operationThe 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 PACUduring in PACU, an average of 1 hourAssessment of hoarseness in PACU following surgery
Numerical Rating Scale for cough intensity at 8 weeks post-operationat 8 weeks post-operationThe 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.
Leicester Cough Questionnaire for Measuring Chronic Cough at 8 weeks post-operationat 8 weeks post-operationThe 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.
Incidence of postoperative cough following lung resection at 8 weeks post-operationat 8 weeks post-operationThe incidence of post-lung resection cough was assessed at 8 weeks postoperatively.

Countries

China

Contacts

Primary ContactLina Yu, doctor
zryulina@zju.edu.cn+8613958033387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026