Effects of Intraoperative Vagal Block on Reducing the Postoperative Cough After Thoracic Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Cough; Thoracic Surgery; Nerve Block
• Intervention / Treatment: Procedure: Vagus nerve block; Procedure: No vagus nerve block

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seong Yong Park; Phone Number: 82-2-2228-2142; Email: SYPARKCS@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei Severance Hospital
    • Contact: Seong Yong Park; Phone Number: 82-2-2228-2142; Email: SYPARKCS@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VNB (vagus nerve block); Vagus nerve block	Procedure: 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.
Placebo Comparator: Control; No vagus nerve block	Procedure: No vagus nerve block; No vagus nerve block will be conducted during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after surgery
Cough numeric rating scales (NRS)	The cough NRS range from 0 (no cough at all) to 10 (maximal cough).	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.	6 months after surgery

Collaborators and Investigators

• Sponsor: Severance Hospital
• Investigators: Principal Investigator: Seong Yong Park, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 4-2020-1087

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