Atrial FibrillationNCT03919786
Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery
A study testing topical local anesthesia of pulmonary vein combined with vagus nerve block in people with Atrial Fibrillation, run by Han Yuan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- topical local anesthesia of pulmonary vein combined with vagus nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Junli Cao, +86 15162160809, caojl0310@yahoo.com.cn
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- topical local anesthesia of pulmonary vein combined with vagus nerve block
- Keywords
- postoperative atrial fibrillation, lobectomy, thoracic surgery, vagus nerve block, pulmonary myocardial sleeve
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical local anesthesia of pulmonary vein combined with vagus nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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 Receives: Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block |
| normal saline group | Placebo comparator | Same volume of normal saline will be administrated Receives: Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after surgery
Secondary outcomes (33)
the Trail Making Test
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
the Grooved Pegboard Test
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
the Digit Span Test
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
the Number-Symbol Replacement Test
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
the Finger Tapping Test
the neuropsychological test to measure cognitive function.
Measured: 1 day before surgery(baseline)
the Word Fluency Test
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
the Building Block Test
the neuropsychological test to measure cognitive function
Measured: 1 day before surgery(baseline)
Mini-Mental score examination (MMSE)
Mini-Mental score examination [MMSE] used for screening of dementia
Measured: 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).
Measured: 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
Measured: 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.
Measured: 72 hours after surgery
Ventricular rate during POAF
Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
Measured: 72 hours after surgery
Incidence of postoperative delirium
Confusion Assessment Method（CAM) to measure delirium
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15-30 days after surgery
incidence of postoperative complications
incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident
Measured: 1-30 days after surgery
re-admission within 30 days after surgery
incidence and cause of re-admission
Measured: 1-30 days after surgery
mortality
incidence and cause of mortality
Measured: within 30 days after surgery
hospitalization expenses
hospitalization expenses
Measured: up to 30 days after surgery
Postoperative length of stay
Postoperative length of stay
Measured: up to 30 days after surgery
admission into ICU
incidence and length of admission into ICU
Measured: up to 30 days after surgery
Analgesic dose
postoperative analgesic dose converted to morphine equivalents
Measured: 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
Measured: 1 month after surgery
the Trail Making Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
the Grooved Pegboard Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
the Digit Span Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
the Number-Symbol Replacement Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
the Finger Tapping Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
the Word Fluency Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
the Building Block Test
the neuropsychological test to measure cognitive function
Measured: 3-6months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Apr 2019
- Primary completion30 May 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919786
- Sponsor's protocol ID
- XYFY2019-KL002-02
- Status last verified
- Dec 2019
- First submitted
- 5 Apr 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03919786
- Acronym / sponsor ID
- XYFY2019-KL002-02
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative atrial fibrillation, lobectomy, thoracic surgery, vagus nerve block, pulmonary myocardial sleeve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Han YuanUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve blockDurg：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 |
| normal saline group | Placebo comparator | Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve blockSame volume of normal saline will be administrated |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical local anesthesia of pulmonary vein combined with vagus nerve blockInjecting 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. | Procedure or surgery | intervention group, normal saline group |
Primary outcome
incidence of POAF
Time frame: 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.
33 secondary outcomes
the Trail Making Test
Time frame: 1 day before surgery(baseline)
the Grooved Pegboard Test
Time frame: 1 day before surgery(baseline)
the Digit Span Test
Time frame: 1 day before surgery(baseline)
the Number-Symbol Replacement Test
Time frame: 1 day before surgery(baseline)
the Finger Tapping Test
Time frame: 1 day before surgery(baseline)
the Word Fluency Test
Time frame: 1 day before surgery(baseline)
the Building Block Test
Time frame: 1 day before surgery(baseline)
Mini-Mental score examination (MMSE)
Time frame: 1 day before surgery(baseline)，6±1 days after surgery，one month after surgery
Quality of Recovery Score - 40 (QoR-40)
Time frame: 1 day before surgery(baseline)，1 day after surgery
specific time of POAF
Time frame: 72 hours after surgery
incidence of other arrhythmia
Time frame: 72 hours after surgery
Ventricular rate during POAF
Time frame: 72 hours after surgery
Incidence of postoperative delirium
Time frame: before discharge from PACU，twice a day every 12 hours within 3 days after surgery
Numerical Rating Scale（NRS）
Time frame: before discharge from PACU，twice a day every 12 hours within 3 days after surgery
incidence of POAF
Time frame: 4-14 days after surgery
incidence of other arrhythmia
Time frame: 4-14 days after surgery
incidence of POAF
Time frame: 15-30 days after surgery
incidence of other arrhythmia
Time frame: 15-30 days after surgery
incidence of postoperative complications
Time frame: 1-30 days after surgery
re-admission within 30 days after surgery
Time frame: 1-30 days after surgery
mortality
Time frame: within 30 days after surgery
hospitalization expenses
Time frame: up to 30 days after surgery
Postoperative length of stay
Time frame: up to 30 days after surgery
admission into ICU
Time frame: up to 30 days after surgery
Analgesic dose
Time frame: up to 7 days after surgery
incidence of second operation
Time frame: 1 month after surgery
the Trail Making Test
Time frame: 3-6months after surgery
the Grooved Pegboard Test
Time frame: 3-6months after surgery
the Digit Span Test
Time frame: 3-6months after surgery
the Number-Symbol Replacement Test
Time frame: 3-6months after surgery
the Finger Tapping Test
Time frame: 3-6months after surgery
the Word Fluency Test
Time frame: 3-6months after surgery
the Building Block Test
Time frame: 3-6months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical local anesthesia of pulmonary vein combined with vagus nerve block in people with Atrial Fibrillation, run by Han Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junli Cao (+86 15162160809, caojl0310@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of POAF (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.