An interventional study of Vagus nerve block and No vagus nerve block in Cough, Thoracic Surgery and Nerve Block, sponsored by Severance Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Severance Hospital · Not applicable, Interventional, and Treatment
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
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vagus nerve block
Procedure: Vagus nerve block
No vagus nerve block
Procedure: No vagus nerve block
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 block will be conducted during the surgery.
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.
Time frame: 6 months after surgery
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.
Time frame: 6 months after surgery
Cough numeric rating scales (NRS)
The cough NRS range from 0 (no cough at all) to 10 (maximal cough).
Time frame: 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.
Time frame: 6 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Nov 2022, 23 months after the start.
Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 23 months is above that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Severance Hospital