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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03919786

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted December 5, 2019

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:Atrial Fibrillation
  • Intervention/Treatment: Procedure: topical local anesthesia of pulmonary vein combined with vagus nerve block
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • 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: April 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: July 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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. the Building Block Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
  • 2. the Finger Tapping Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
  • 3. the Word Fluency Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function
  • 4. the Word Fluency Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
  • 5. the Trail Making Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function
  • 6. the Grooved Pegboard Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function
  • 7. the Digit Span Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function
  • 8. the Number-Symbol Replacement Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function
  • 9. the Finger Tapping Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function.
  • 10. the Building Block Test [ Time Frame: 1 day before surgery(baseline) ]
    the neuropsychological test to measure cognitive function
  • 11. Mini-Mental score examination (MMSE) [ Time Frame: 1 day before surgery(baseline),6±1 days after surgery,one month after surgery ]
    Mini-Mental score examination [MMSE] used for screening of dementia
  • 12. Quality of Recovery Score - 40 (QoR-40) [ Time Frame: 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).
  • 13. specific time of POAF [ Time Frame: 72 hours after surgery ]
    Specific time of POAF,such as 9:00AM,first day after surgery
  • 14. incidence of other arrhythmia [ 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.
  • 15. Ventricular rate during POAF [ Time Frame: 72 hours after surgery ]
    Continuous ECG recordings were made on Holter recorders for 72 hours after the operation.
  • 16. Incidence of postoperative delirium [ Time Frame: before discharge from PACU,twice a day every 12 hours within 3 days after surgery ]
    Confusion Assessment Method(CAM) to measure delirium
  • 17. Numerical Rating Scale(NRS) [ Time Frame: 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.
  • 18. incidence of POAF [ Time Frame: 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.
  • 19. incidence of other arrhythmia [ Time Frame: 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.
  • 20. incidence of POAF [ Time Frame: 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.
  • 21. incidence of other arrhythmia [ Time Frame: 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.
  • 22. incidence of postoperative complications [ Time Frame: 1-30 days after surgery ]
    incidence of respiratory complications, intestinal obstruction, acute renal failure, wound infection, cerebrovascular accident
  • 23. re-admission within 30 days after surgery [ Time Frame: 1-30 days after surgery ]
    incidence and cause of re-admission
  • 24. mortality [ Time Frame: within 30 days after surgery ]
    incidence and cause of mortality
  • 25. hospitalization expenses [ Time Frame: up to 30 days after surgery ]
    hospitalization expenses
  • 26. Postoperative length of stay [ Time Frame: up to 30 days after surgery ]
    Postoperative length of stay
  • 27. admission into ICU [ Time Frame: up to 30 days after surgery ]
    incidence and length of admission into ICU
  • 28. Analgesic dose [ Time Frame: up to 7 days after surgery ]
    postoperative analgesic dose converted to morphine equivalents
  • 29. incidence of second operation [ Time Frame: 1 month after surgery ]
    incidence of unplanned second operation due to direct or indirect complications of the original surgery
  • 30. the Trail Making Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
  • 31. the Grooved Pegboard Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
  • 32. the Digit Span Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
  • 33. the Number-Symbol Replacement Test [ Time Frame: 3-6months after surgery ]
    the neuropsychological test to measure cognitive function
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Junli Cao +86 15162160809 caojl0310@yahoo.com.cn

Locations

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

Sponsors and Collaborators

Han Yuan

More Information
  • Responsible Party: Han Yuan
  • ClinicalTrials.gov Identifier: NCT03919786 History of Changes
  • Other Study ID Numbers: XYFY2019-KL002-02
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: December 5, 2019
  • Last Verified: December 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Han Yuan: lobectomy
    thoracic surgery
    vagus nerve block
    pulmonary myocardial sleeve
    postoperative atrial fibrillation
  • Additional relevant MeSH terms: Atrial Fibrillation