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

Sponsor

Han Yuan (Other)

Overall Status

Unknown status

CT.gov ID

NCT03919786

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Intervention is not blinded to anesthesiologists and nurses participating intraoperative management.These anesthesiologists and nurses will not participate the follow-up study of this patient.Surgeons performing surgery are blinded.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

May 30, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

incidence of POAF [72 hours after surgery]
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.

Secondary Outcome Measures

the Trail Making Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function
the Grooved Pegboard Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function
the Digit Span Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function
the Number-Symbol Replacement Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function
the Finger Tapping Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function.
the Word Fluency Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function
the Building Block Test [1 day before surgery(baseline)]
the neuropsychological test to measure cognitive function
Mini-Mental score examination (MMSE) [1 day before surgery(baseline)，6±1 days after surgery，one month after surgery]
Mini-Mental score examination [MMSE] used for screening of dementia
Quality of Recovery Score - 40 (QoR-40) [1 day before surgery(baseline)，1 day after surgery]
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).
specific time of POAF [72 hours after surgery]
Specific time of POAF，such as 9：00AM，first day after surgery
incidence of other arrhythmia [72 hours after surgery]
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.
Ventricular rate during POAF [72 hours after surgery]
Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
Incidence of postoperative delirium [before discharge from PACU，twice a day every 12 hours within 3 days after surgery]
Confusion Assessment Method（CAM) to measure delirium
Numerical Rating Scale（NRS） [before discharge from PACU，twice a day every 12 hours within 3 days after surgery]
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
incidence of POAF [4-14 days after surgery]
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
incidence of other arrhythmia [4-14 days after surgery]
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
incidence of POAF [15-30 days after surgery]
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
incidence of other arrhythmia [15-30 days after surgery]
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
incidence of postoperative complications [1-30 days after surgery]
incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident
re-admission within 30 days after surgery [1-30 days after surgery]
incidence and cause of re-admission
mortality [within 30 days after surgery]
incidence and cause of mortality
hospitalization expenses [up to 30 days after surgery]
hospitalization expenses
Postoperative length of stay [up to 30 days after surgery]
Postoperative length of stay
admission into ICU [up to 30 days after surgery]
incidence and length of admission into ICU
Analgesic dose [up to 7 days after surgery]
postoperative analgesic dose converted to morphine equivalents
incidence of second operation [1 month after surgery]
incidence of unplanned second operation due to direct or indirect complications of the original surgery
the Trail Making Test [3-6months after surgery]
the neuropsychological test to measure cognitive function
the Grooved Pegboard Test [3-6months after surgery]
the neuropsychological test to measure cognitive function
the Digit Span Test [3-6months after surgery]
the neuropsychological test to measure cognitive function
the Number-Symbol Replacement Test [3-6months after surgery]
the neuropsychological test to measure cognitive function
the Finger Tapping Test [3-6months after surgery]
the neuropsychological test to measure cognitive function
the Word Fluency Test [3-6months after surgery]
the neuropsychological test to measure cognitive function
the Building Block Test [3-6months after surgery]
the neuropsychological test to measure cognitive function

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China

Sponsors and Collaborators

Han Yuan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University

ClinicalTrials.gov Identifier:

NCT03919786

Other Study ID Numbers:

XYFY2019-KL002-02

First Posted:

Apr 18, 2019

Last Update Posted:

Dec 5, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University

postoperative atrial fibrillation

lobectomy

thoracic surgery

vagus nerve block

pulmonary myocardial sleeve

Additional relevant MeSH terms:

Atrial Fibrillation

Anesthetics

Study Results

No Results Posted as of Dec 5, 2019