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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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<br>* 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.<br>|
| Placebo Comparator: normal saline group<br>Same volume of normal saline will be administrated | Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative atrial fibrillation, lobectomy, thoracic surgery, vagus nerve block, pulmonary myocardial sleeve