Postoperative CoughNCT06500949
Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After VATS Lung Resection
A study testing Vagus Nerve Pulmonary Branch Block and Vagus Nerve Pulmonary Branch Injection in people with Postoperative Cough and Thoracoscopy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Cough, Thoracoscopy, Pulmonary Resection
- What is being tested?
- Vagus Nerve Pulmonary Branch Block and Vagus Nerve Pulmonary Branch Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second affiliated Hospital School of Medicine,Zhejiang University
Hangzhou, Zhejiang
Lina Yu, doctor, +8613958033387, zryulina@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Postoperative Cough, Thoracoscopy, Pulmonary Resection, Vagus, Nerve Block
- Being tested
- Vagus Nerve Pulmonary Branch Block, Vagus Nerve Pulmonary Branch Injection
- Keywords
- Chronic cough, Postoperative cough, Thoracoscopy or Video-assisted thoracoscopic surgery, Pulmonary resection or Lung resection, Vagus
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Pulmonary Branch BlockProcedure or surgery
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 InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Vagus Nerve Pulmonary Branch Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 weeks post-operation
Secondary outcomes (7)
Condition of hoarseness in PACU
Assessment of hoarseness in PACU following surgery
Measured: during in PACU, an average of 1 hour
Peak expiratory flow rate on postoperative day 1
Measurement of peak expiratory flow on postoperative day 1
Measured: on postoperative day 1
Numerical Rating Scale for cough intensity 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.
Measured: at 3 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough 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.
Measured: at 3 weeks post-operation
Incidence of postoperative cough following lung resection at 8 weeks post-operation
The incidence of post-lung resection cough was assessed at 8 weeks postoperatively.
Measured: at 8 weeks post-operation
Numerical Rating Scale for cough intensity 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.
Measured: at 8 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough 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.
Measured: at 8 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start15 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CoughStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500949
- Sponsor's protocol ID
- 2024-0618
- Status last verified
- Jun 2024
- First submitted
- 8 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After Thoracoscopic Lung Resection
- ClinicalTrials.gov ID
- NCT06500949
- Acronym / sponsor ID
- 2024-0618
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve pulmonary branch block group (V group) | Experimental | Procedure: Vagus Nerve Pulmonary Branch BlockAfter 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. |
| Control group (C group) | Placebo comparator | Procedure: Vagus Nerve Pulmonary Branch InjectionAfter 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve Pulmonary Branch BlockFollowing 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. | Procedure or surgery | Vagus nerve pulmonary branch block group (V group) |
| Vagus Nerve Pulmonary Branch InjectionFollowing 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. | Procedure or surgery | Control group (C group) |
Primary outcome
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.
7 secondary outcomes
Condition of hoarseness in PACU
Time frame: during in PACU, an average of 1 hour
Peak expiratory flow rate on postoperative day 1
Time frame: on postoperative day 1
Numerical Rating Scale for cough intensity at 3 weeks post-operation
Time frame: at 3 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operation
Time frame: at 3 weeks post-operation
Incidence of postoperative cough following lung resection at 8 weeks post-operation
Time frame: at 8 weeks post-operation
Numerical Rating Scale for cough intensity at 8 weeks post-operation
Time frame: at 8 weeks post-operation
Leicester Cough Questionnaire for Measuring Chronic Cough at 8 weeks post-operation
Time frame: at 8 weeks post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Pulmonary Branch Block and Vagus Nerve Pulmonary Branch Injection in people with Postoperative Cough and Thoracoscopy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lina Yu, doctor (+8613958033387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cough following lung resection at 3 weeks post-operation (time frame: at 3 weeks post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.