Back to resultsEffects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
topical local anesthesia of pulmonary vein combined with vagus nerve block
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring postoperative atrial fibrillation, lobectomy, thoracic surgery, vagus nerve block, pulmonary myocardial sleeve
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention group
normal saline group
Arm Description
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
Same volume of normal saline will be administrated
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
the Trail Making Test
the neuropsychological test to measure cognitive function
the Grooved Pegboard Test
the neuropsychological test to measure cognitive function
the Digit Span Test
the neuropsychological test to measure cognitive function
the Number-Symbol Replacement Test
the neuropsychological test to measure cognitive function
the Finger Tapping Test
the neuropsychological test to measure cognitive function.
the Word Fluency Test
the neuropsychological test to measure cognitive function
the Building Block Test
the neuropsychological test to measure cognitive function
Mini-Mental score examination (MMSE)
Mini-Mental score examination [MMSE] used for screening of dementia
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).
specific time of POAF
Specific time of POAF，such as 9：00AM，first day 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.
Ventricular rate during POAF
Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
Incidence of postoperative delirium
Confusion Assessment Method（CAM) to measure delirium
Numerical Rating Scale（NRS）
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
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.
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.
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.
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.
incidence of postoperative complications
incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident
re-admission within 30 days after surgery
incidence and cause of re-admission
mortality
incidence and cause of mortality
hospitalization expenses
hospitalization expenses
Postoperative length of stay
Postoperative length of stay
admission into ICU
incidence and length of admission into ICU
Analgesic dose
postoperative analgesic dose converted to morphine equivalents
incidence of second operation
incidence of unplanned second operation due to direct or indirect complications of the original surgery
the Trail Making Test
the neuropsychological test to measure cognitive function
the Grooved Pegboard Test
the neuropsychological test to measure cognitive function
the Digit Span Test
the neuropsychological test to measure cognitive function
the Number-Symbol Replacement Test
the neuropsychological test to measure cognitive function
the Finger Tapping Test
the neuropsychological test to measure cognitive function
the Word Fluency Test
the neuropsychological test to measure cognitive function
the Building Block Test
the neuropsychological test to measure cognitive function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03919786
Brief Title
Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Yuan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
postoperative atrial fibrillation, lobectomy, thoracic surgery, vagus nerve block, pulmonary myocardial sleeve
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
normal saline group
Arm Type
Placebo Comparator
Arm Description
Same volume of normal saline will be administrated
Intervention Type
Procedure
Intervention Name(s)
topical local anesthesia of pulmonary vein combined with vagus nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of POAF
Description
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.
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
the Trail Making Test
Description
the neuropsychological test to measure cognitive function
Time Frame
1 day before surgery(baseline)
Title
the Grooved Pegboard Test
Description
the neuropsychological test to measure cognitive function
Time Frame
1 day before surgery(baseline)
Title
the Digit Span Test
Description
the neuropsychological test to measure cognitive function
Time Frame
1 day before surgery(baseline)
Title
the Number-Symbol Replacement Test
Description
the neuropsychological test to measure cognitive function
Time Frame
1 day before surgery(baseline)
Title
the Finger Tapping Test
Description
the neuropsychological test to measure cognitive function.
Time Frame
1 day before surgery(baseline)
Title
the Word Fluency Test
Description
the neuropsychological test to measure cognitive function
Time Frame
1 day before surgery(baseline)
Title
the Building Block Test
Description
the neuropsychological test to measure cognitive function
Time Frame
1 day before surgery(baseline)
Title
Mini-Mental score examination (MMSE)
Description
Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame
1 day before surgery(baseline)，6±1 days after surgery，one month after surgery
Title
Quality of Recovery Score - 40 (QoR-40)
Description
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).
Time Frame
1 day before surgery(baseline)，1 day after surgery
Title
specific time of POAF
Description
Specific time of POAF，such as 9：00AM，first day after surgery
Time Frame
72 hours after surgery
Title
incidence of other arrhythmia
Description
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.
Time Frame
72 hours after surgery
Title
Ventricular rate during POAF
Description
Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
Time Frame
72 hours after surgery
Title
Incidence of postoperative delirium
Description
Confusion Assessment Method（CAM) to measure delirium
Time Frame
before discharge from PACU，twice a day every 12 hours within 3 days after surgery
Title
Numerical Rating Scale（NRS）
Description
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Time Frame
before discharge from PACU，twice a day every 12 hours within 3 days after surgery
Title
incidence of POAF
Description
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
Time Frame
4-14 days after surgery
Title
incidence of other arrhythmia
Description
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
Time Frame
4-14 days after surgery
Title
incidence of POAF
Description
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
Time Frame
15-30 days after surgery
Title
incidence of other arrhythmia
Description
Conduct electrocardiogram in patients with heartache or other symptoms.The decisions made by an experienced technician and then confirmed by a cardiologist.
Time Frame
15-30 days after surgery
Title
incidence of postoperative complications
Description
incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident
Time Frame
1-30 days after surgery
Title
re-admission within 30 days after surgery
Description
incidence and cause of re-admission
Time Frame
1-30 days after surgery
Title
mortality
Description
incidence and cause of mortality
Time Frame
within 30 days after surgery
Title
hospitalization expenses
Description
hospitalization expenses
Time Frame
up to 30 days after surgery
Title
Postoperative length of stay
Description
Postoperative length of stay
Time Frame
up to 30 days after surgery
Title
admission into ICU
Description
incidence and length of admission into ICU
Time Frame
up to 30 days after surgery
Title
Analgesic dose
Description
postoperative analgesic dose converted to morphine equivalents
Time Frame
up to 7 days after surgery
Title
incidence of second operation
Description
incidence of unplanned second operation due to direct or indirect complications of the original surgery
Time Frame
1 month after surgery
Title
the Trail Making Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
Title
the Grooved Pegboard Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
Title
the Digit Span Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
Title
the Number-Symbol Replacement Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
Title
the Finger Tapping Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
Title
the Word Fluency Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
Title
the Building Block Test
Description
the neuropsychological test to measure cognitive function
Time Frame
3-6months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junli Cao
Phone
+86 15162160809
Email
caojl0310@yahoo.com.cn
Facility Information:
Facility Name
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junli Cao
Phone
+86 15162160809
Email
caojl0310@yahoo.com.cn
12. IPD Sharing Statement
Learn more about this trial
Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
We'll reach out to this number within 24 hrs