Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
Primary Purpose
Cough, Thoracic Surgery, Nerve Block
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vagus nerve block
No vagus nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Cough
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Yonsei Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
VNB (vagus nerve block)
Control
Arm Description
Vagus nerve block
No vagus nerve block
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Cough numeric rating scales (NRS)
The cough NRS range from 0 (no cough at all) to 10 (maximal cough).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04672694
Brief Title
Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
Official Title
Randomized Controlled Study of Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Thoracic Surgery, Nerve Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VNB (vagus nerve block)
Arm Type
Active Comparator
Arm Description
Vagus nerve block
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No vagus nerve block
Intervention Type
Procedure
Intervention Name(s)
Vagus nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No vagus nerve block
Intervention Description
No vagus nerve block will be conducted during the surgery.
Primary Outcome Measure Information:
Title
Cough score
Description
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
Secondary Outcome Measure Information:
Title
COAT, Cough Assessment Test
Description
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
Title
Cough numeric rating scales (NRS)
Description
The cough NRS range from 0 (no cough at all) to 10 (maximal cough).
Time Frame
6 months after surgery
Title
Leicester cough questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong Yong Park
Phone
82-2-2228-2142
Email
SYPARKCS@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Yong Park
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Yong Park
Phone
82-2-2228-2142
Email
SYPARKCS@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery
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