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

NCT ID: NCT06500949

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vagus Nerve Pulmonary Branch Block

Intervention Type: PROCEDURE

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.

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.

Group Type: PLACEBO_COMPARATOR

Vagus Nerve Pulmonary Branch Injection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lina Yu, doctor

Role: CONTACT

zryulina@zju.edu.cn

+8613958033387

Facility Contacts

Lina Yu, doctor

Role: primary

zryulina@zju.edu.cn

+8613958033387

Other Identifiers

2024-0618

Identifier Type: -

Identifier Source: org_study_id