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

Zhejiang University

Status: Enrolling

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

Treatments: Procedure: Vagus Nerve Pulmonary Branch Block; Procedure: Vagus Nerve Pulmonary Branch Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06500949

2024-0618

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups, including a placebo group

Vagus nerve pulmonary branch block group (V group)

Experimental group

Description:

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.

Treatment:

Procedure: Vagus Nerve Pulmonary Branch Block

Control group (C group)

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Vagus Nerve Pulmonary Branch Injection