CoughNCT04672694
Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
A study testing Vagus nerve block and No vagus nerve block in people with Cough and Thoracic Surgery, run by Severance Hospital at 1 site in South Korea.
Trial summary
Randomized controlled study to investigate the role of intraoperative vagal nerve block for preventing the postoperative cough in patients who received the pulmonary resection for lung cancer Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cough, Thoracic Surgery, Nerve Block
- What is being tested?
- Vagus nerve block and No vagus nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Dec 2020to Nov 2023
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists' physical status class Ⅲ
- Diagnosed with non-small cell lung cancer with clinical stage of I-IIIA
- Planned to undergo segmentectomy or lobectomy with mediastinal lymph node dissection
Who cannot join
- chronic cough symptoms before surgery; a chronic cough (a cough lasting more than eight weeks)
- chemotherapy or chemoradiotherapy prior to surgery
- current smoker (patient should quit smoking at least 2 weeks before surgery)
- previously diagnosed with airway disease prior to surgery
- previously diagnosed with asthma prior to surgery
- patients with nervous system defects or psychiatric problems
- patients with severe cardiovascular disease, hepatological, or renal failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Seong Yong Park, 82-2-2228-2142, SYPARKCS@yuhs.ac
About this study
Official title: Randomized Controlled Study of Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
Randomized controlled study to investigate the role of intraoperative vagal nerve block for preventing the postoperative cough in patients who received the pulmonary resection for lung cancer
Read the detailed description
The standard treatments for early primary lung cancer are surgical treatments (lobectomy and lymph node resection). The usual mortality rate of lung cancer surgery is 1-2%, and the incidence of complications is reported to be about 20%. In addition to these deaths and complications, there are frequent sequelae such as reduction of pulmonary function reduction and cough. According to a cross section study of 240 patients who underwent lung cancer surgery, about 30% of patients complained of cough after surgery for one year after surgery, and 50% of patients complained of cough after one year. After the pulmonary resection of lung cancer, chronic coughs are the main cause of lowering the quality of life of patients after lung surgery. Several studies have reported the risk factors of cough after lung cancer surgery, and it is known that there is a relationship between mediastinal lymph node resection and accompanying gastric-esophageal gastric acid reflux.
According to anatomy and physiology studies of coughs, coughing occurs due to stimulation of vagus nerves, which is a type of reflex to protect the respiratory tract from harmful stimuli from the outside. Cough cough is known to occur when c-fibers are stimulated, especially at the end of the vagus nerve. Cough reflex-related circuits from c-fiber to brain are generated, and then coughing is reported in smaller stimuli. The end of the vagus nerves in the bronchial area can be damaged by the mediastinal lymph nodes dissection during lung cancer surgery and it can lead to c-fiber stimulation and finally form the nerve circuit which can lead to chronic cough.
Recently, awake pulmonary resection (awakening surgery) has been performed in several countries. Normally, sleep anesthesia gas itself is depleted of vagus nerve function and does not cause cough reflex during surgery, but when operated in a waking state, coughing caused by vagus nerve stimulation may occur and dangerous situations may occur during surgery, so it is reported that vagus nerve block is performed at the start of surgery. These vagus nerve blocks are known to prevent cough reflex during awakening surgery and enable surgery to be performed stably. However, it is not yet known whether these vagus nerve block can reduce acute and chronic cough after surgery. In this study, we investigated whether vagus nerve block during surgery could reduce coughing after surgery in patients who underwent general anesthesia lung cancer surgery.
- Conditions
- Cough, Thoracic Surgery, Nerve Block
- Being tested
- Vagus nerve block, No vagus nerve block
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve blockProcedure or surgery
Ropivacine 0.75% 2mL will be injected two times around the vagus nerve (just below the bifurcation of recurrent laryngeal nerve); one before starting the surgical resection of lung including complete mediasitnal lymph node dissection and one at the end of operation.
No vagus nerve blockProcedure or surgery
No vagus nerve block will be conducted during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| VNB (vagus nerve block) | Active comparator | Vagus nerve block Receives: Procedure: Vagus nerve block |
| Control | Placebo comparator | No vagus nerve block Receives: Procedure: No vagus nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough score
The cough score is a two-part questionnaire referring to a symptoms during the day and night time. The response scale captures cough frequency, intensity and overall impact.
Measured: 6 months after surgery
Secondary outcomes (3)
COAT, Cough Assessment Test
The COAT is a short, simple questionnaire that assesses cough frequency, limitation on daily activities, sleep disturbance, fatigue and hypersensitivity to irritants in recent 1 week. It consists of five items, each with a 5-point differential scale (0-4), constituting a 0-20-point total scale.
Measured: 6 months after surgery
Cough numeric rating scales (NRS)
The cough NRS range from 0 (no cough at all) to 10 (maximal cough).
Measured: 6 months after surgery
Leicester cough questionnaire
LCQ is a validated self-reporting quality of life measures of cough in recent 2 weeks. It consists of 19 items with a 7 point likert response scale (range from 1 to 7) and it takes less than 5 minutes to complete.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start29 Dec 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Yong Park, Severance Hospital
- Investigators
- Seong Yong Park, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672694
- Sponsor's protocol ID
- 4-2020-1087
- Status last verified
- Jan 2021
- First submitted
- 6 Dec 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04672694
- Acronym / sponsor ID
- 4-2020-1087
- Conditions
- Cough, Thoracic Surgery, Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 17 Dec 2020 (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.
Randomized controlled study to investigate the role of intraoperative vagal nerve block for preventing the postoperative cough in patients who received the pulmonary resection for lung cancer
Detailed description
The standard treatments for early primary lung cancer are surgical treatments (lobectomy and lymph node resection). The usual mortality rate of lung cancer surgery is 1-2%, and the incidence of complications is reported to be about 20%. In addition to these deaths and complications, there are frequent sequelae such as reduction of pulmonary function reduction and cough. According to a cross section study of 240 patients who underwent lung cancer surgery, about 30% of patients complained of cough after surgery for one year after surgery, and 50% of patients complained of cough after one year. After the pulmonary resection of lung cancer, chronic coughs are the main cause of lowering the quality of life of patients after lung surgery. Several studies have reported the risk factors of cough after lung cancer surgery, and it is known that there is a relationship between mediastinal lymph node resection and accompanying gastric-esophageal gastric acid reflux.
According to anatomy and physiology studies of coughs, coughing occurs due to stimulation of vagus nerves, which is a type of reflex to protect the respiratory tract from harmful stimuli from the outside. Cough cough is known to occur when c-fibers are stimulated, especially at the end of the vagus nerve. Cough reflex-related circuits from c-fiber to brain are generated, and then coughing is reported in smaller stimuli. The end of the vagus nerves in the bronchial area can be damaged by the mediastinal lymph nodes dissection during lung cancer surgery and it can lead to c-fiber stimulation and finally form the nerve circuit which can lead to chronic cough.
Recently, awake pulmonary resection (awakening surgery) has been performed in several countries. Normally, sleep anesthesia gas itself is depleted of vagus nerve function and does not cause cough reflex during surgery, but when operated in a waking state, coughing caused by vagus nerve stimulation may occur and dangerous situations may occur during surgery, so it is reported that vagus nerve block is performed at the start of surgery. These vagus nerve blocks are known to prevent cough reflex during awakening surgery and enable surgery to be performed stably. However, it is not yet known whether these vagus nerve block can reduce acute and chronic cough after surgery. In this study, we investigated whether vagus nerve block during surgery could reduce coughing after surgery in patients who underwent general anesthesia lung cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNB (vagus nerve block) | Active comparator | Procedure: Vagus nerve blockVagus nerve block |
| Control | Placebo comparator | Procedure: No vagus nerve blockNo vagus nerve block |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists' physical status class Ⅲ
- Diagnosed with non-small cell lung cancer with clinical stage of I-IIIA
- Planned to undergo segmentectomy or lobectomy with mediastinal lymph node dissection
Key exclusion criteria (7 listed)
- chronic cough symptoms before surgery; a chronic cough (a cough lasting more than eight weeks)
- chemotherapy or chemoradiotherapy prior to surgery
- current smoker (patient should quit smoking at least 2 weeks before surgery)
- previously diagnosed with airway disease prior to surgery
- previously diagnosed with asthma prior to surgery
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 blockRopivacine 0.75% 2mL will be injected two times around the vagus nerve (just below the bifurcation of recurrent laryngeal nerve); one before starting the surgical resection of lung including complete mediasitnal lymph node dissection and one at the end of operation. | Procedure or surgery | VNB (vagus nerve block) |
| No vagus nerve blockNo vagus nerve block will be conducted during the surgery. | Procedure or surgery | Control |
Primary outcome
Cough score
Time frame: 6 months after surgery
The cough score is a two-part questionnaire referring to a symptoms during the day and night time. The response scale captures cough frequency, intensity and overall impact.
3 secondary outcomes
COAT, Cough Assessment Test
Time frame: 6 months after surgery
Cough numeric rating scales (NRS)
Time frame: 6 months after surgery
Leicester cough questionnaire
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- 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.
Seong Yong Park principal investigator
Severance Hospital
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 block and No vagus nerve block in people with Cough and Thoracic Surgery, run by Severance Hospital at 1 site in South Korea.
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 3 inclusion and 7 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 12 Jan 2021. 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 South Korea. 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 Seong Yong Park (82-2-2228-2142, SYPARKCS@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough score (time frame: 6 months after surgery). 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 12 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.