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

July 25, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Second affiliated Hospital School of Medicine,Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: 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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of postoperative cough following lung resection at 3 weeks post-operation
Time Frame: at 3 weeks post-operation
The incidence of post-lung resection cough was assessed at 3 weeks postoperatively.
at 3 weeks post-operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Condition of hoarseness in PACU
Time Frame: during in PACU, an average of 1 hour
Assessment of hoarseness in PACU following surgery
during in PACU, an average of 1 hour
Peak expiratory flow rate on postoperative day 1
Time Frame: on postoperative day 1
Measurement of peak expiratory flow on postoperative day 1
on postoperative day 1
Incidence of postoperative cough following lung resection at 8 weeks post-operation
Time Frame: at 8 weeks post-operation
The incidence of post-lung resection cough was assessed at 8 weeks postoperatively.
at 8 weeks post-operation
Numerical Rating Scale for cough intensity at 3 weeks post-operation
Time Frame: at 3 weeks post-operation
The 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.
at 3 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operation
Time Frame: at 3 weeks post-operation
The 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.
at 3 weeks post-operation
Numerical Rating Scale for cough intensity at 8 weeks post-operation
Time Frame: at 8 weeks post-operation
The 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.
at 8 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough at 8 weeks post-operation
Time Frame: at 8 weeks post-operation
The 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.
at 8 weeks post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-0618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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