Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery

Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery: a Double-blinded Randomized Placebo Controlled Trials

This study intends to explore a new therapy to reduce the incidence of atrial fibrillation in thoracic patient who receive video-assisted thoracoscopic lobectomy .The results of the study are to assess the effects of this new intervention on the incidence，duration of atrial fibrillation and other complications including postoperative delirium after video-assisted thoracoscopic lobectomy .And reducing the burden of POAF on patients and their families, hospitals and public resources.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Thoracoscopic lobectomy and bilobectomy
• ASA class I-III
• Age is greater than or equal to 50 years old
• Han Nationality, mother tongue is chinese
• The people signed informed consent

Exclusion Criteria:

• history of chronic atrial arrhythmia
• sick sinus syndrome
• history of second-degree atrioventricular block
• taking class I or class III antiarrhythmic drugs or β-receptor blocker
• history of radiofrequency ablation
• hyperthyroidism
• contraindications of ropivacaine, lidocaine
• pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Durg：0.375% Ropivacaine and 1% lidocaine topical local anesthesia of pulmonary vein with lidocaine+ropivacaine at the beginning and the end of surgery operation. Block vagus nerve with lidocaine+ropivacaine 1ml after exposing the pleural apex	Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block; Injecting 1% lidocaine 1.5ml+0.375% ropivacaine 1.5ml into vascular sheaths of all pulmonary vein of the surgery side at the beginning of surgery operation. Wrapping all pulmonary vein of the surgery side with cotton sheet infiltrated with 1% lidocaine+0.375% ropivacaine at the end of surgery operation. Blocking vagus nerve above the aortic vein on the right side of the trachea with 1% lidocaine 1ml+0.375% ropivacaine 1ml after exposing the pleural apex.
Placebo Comparator: normal saline group; Same volume of normal saline will be administrated	Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block; Injecting 1% lidocaine 1.5ml+0.375% ropivacaine 1.5ml into vascular sheaths of all pulmonary vein of the surgery side at the beginning of surgery operation. Wrapping all pulmonary vein of the surgery side with cotton sheet infiltrated with 1% lidocaine+0.375% ropivacaine at the end of surgery operation. Blocking vagus nerve above the aortic vein on the right side of the trachea with 1% lidocaine 1ml+0.375% ropivacaine 1ml after exposing the pleural apex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of POAF	Continuous ECG recordings were made on Holter recorders for 72 hours after the operation. Arrhythmia detection were done automatically by template matching. The decisions made automatically by the computer were reviewed and corrected by an experienced technician and then by a cardiologist.	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Trail Making Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
the Grooved Pegboard Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
the Digit Span Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
the Number-Symbol Replacement Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
the Finger Tapping Test	the neuropsychological test to measure cognitive function.	1 day before surgery(baseline)
the Word Fluency Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
the Building Block Test	the neuropsychological test to measure cognitive function	1 day before surgery(baseline)
Mini-Mental score examination (MMSE)	Mini-Mental score examination [MMSE] used for screening of dementia	1 day before surgery(baseline)，6±1 days after surgery，one month after surgery
Quality of Recovery Score - 40 (QoR-40)	Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).	1 day before surgery(baseline)，1 day after surgery
specific time of POAF	Specific time of POAF，such as 9：00AM，first day after surgery	72 hours after surgery
incidence of other arrhythmia	Continuous ECG recordings were made on Holter recorders for 72 hours after the operation. Arrhythmia detection were done automatically by template matching. The decisions made automatically by the computer were reviewed and corrected by an experienced technician and then by a cardiologist.	72 hours after surgery
Ventricular rate during POAF	Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.	72 hours after surgery
Incidence of postoperative delirium	Confusion Assessment Method（CAM) to measure delirium	before discharge from PACU，twice a day every 12 hours within 3 days after surgery
Numerical Rating Scale（NRS）	Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.	before discharge from PACU，twice a day every 12 hours within 3 days after surgery
incidence of POAF	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	4-14 days after surgery
incidence of other arrhythmia	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	4-14 days after surgery
incidence of POAF	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	15-30 days after surgery
incidence of other arrhythmia	Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.	15-30 days after surgery
incidence of postoperative complications	incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident	1-30 days after surgery
re-admission within 30 days after surgery	incidence and cause of re-admission	1-30 days after surgery
mortality	incidence and cause of mortality	within 30 days after surgery
hospitalization expenses	hospitalization expenses	up to 30 days after surgery
Postoperative length of stay	Postoperative length of stay	up to 30 days after surgery
admission into ICU	incidence and length of admission into ICU	up to 30 days after surgery
Analgesic dose	postoperative analgesic dose converted to morphine equivalents	up to 7 days after surgery
incidence of second operation	incidence of unplanned second operation due to direct or indirect complications of the original surgery	1 month after surgery
the Trail Making Test	the neuropsychological test to measure cognitive function	3-6months after surgery
the Grooved Pegboard Test	the neuropsychological test to measure cognitive function	3-6months after surgery
the Digit Span Test	the neuropsychological test to measure cognitive function	3-6months after surgery
the Number-Symbol Replacement Test	the neuropsychological test to measure cognitive function	3-6months after surgery
the Finger Tapping Test	the neuropsychological test to measure cognitive function	3-6months after surgery
the Word Fluency Test	the neuropsychological test to measure cognitive function	3-6months after surgery
the Building Block Test	the neuropsychological test to measure cognitive function	3-6months after surgery

Collaborators and Investigators

• Sponsor: Han Yuan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): May 30, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: thoracic surgery; lobectomy; postoperative atrial fibrillation; vagus nerve block; pulmonary myocardial sleeve
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: XYFY2019-KL002-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No