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

NCT06500949 | Recruiting

• 1 other identifier: 2024-0618
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Condition of hoarseness in PACU

  during in PACU, an average of 1 hour

• Peak expiratory flow rate on postoperative day 1

  on postoperative day 1

• Numerical Rating Scale for cough intensity at 3 weeks post-operation

  at 3 weeks post-operation

• Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operation

  at 3 weeks post-operation

• Incidence of postoperative cough following lung resection at 8 weeks post-operation

  at 8 weeks post-operation

Study Arms (2)

Vagus nerve pulmonary branch block group (V group)

EXPERIMENTAL

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

Control group (C group)

PLACEBO COMPARATOR

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

Interventions

Vagus Nerve Pulmonary Branch Block 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.

Vagus nerve pulmonary branch block group (V group)

Vagus Nerve Pulmonary Branch Injection 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.

Control group (C group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lina Yu, doctor

CONTACT

+8613958033387; zryulina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)