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临床试验/NCT06500949
NCT06500949招募中不适用

Effects of Vagus Nerve Pulmonary Branch Block on Postoperative Cough After Thoracoscopic Lung Resection

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
104
试验地点
1
主要终点
Incidence of postoperative cough following lung resection at 3 weeks post-operation

研究概览

简要总结

Postoperative cough after pulmonary resection is a common issue seen after thoracic surgeries, hindering patients' recovery and affecting their postoperative quality of life. While vagus nerve pulmonary branch block has been known to reduce intraoperative coughing, its impact on postoperative cough post lung resection is uncertain. This study aims to assess the effects of vagus nerve pulmonary branch block on postoperative cough after VATS lung resection. A randomized controlled trial involving 104 thoracoscopic lung resection patients will assign them randomly to a vagus nerve pulmonary branch block group or a control group. The primary outcome measure is the postoperative cough incidence 3 weeks after lung resection. The secondary outcomes include assessing hoarseness in PACU, peak expiratory flow (PEF) on the first post-op day, NRS scores for cough, and LCQ-MC scores at 3 weeks post-surgery, as well as cough occurrence, NRS scores, and LCQ-MC scores at 8 weeks post-procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70 years old.
  • BMI between 18 and 30 kilograms per square meter (kg/m²).
  • ASA Physical Status Classification of I, II, or III.
  • Preoperative pulmonary imaging demonstrating peripheral lesions, with clinical staging T≤2, N≤1, M
  • Undergone thoracoscopic lung resection surgery.
  • Patients managed by the same lead surgeon's team.
  • Obtained informed consent, with patients agreeing and signing the informed consent document.

排除标准

  • Patients with a history of chemotherapy or previous pulmonary surgery.
  • Presence of chronic cough due to respiratory infectious diseases, pharyngitis, rhinitis, COPD, asthma, post-nasal drip syndrome, etc.
  • Individuals exhibiting ECG abnormalities such as atrial fibrillation, bundle branch block, frequent ventricular premature beats, pre-excitation syndrome, etc.
  • Currently using ACE inhibitor medications.
  • Presence of preoperative hoarseness.

结局指标

主要结局

Incidence of postoperative cough following lung resection at 3 weeks post-operation

时间窗: at 3 weeks post-operation

The incidence of post-lung resection cough was assessed at 3 weeks postoperatively.

次要结局

  • Peak expiratory flow rate on postoperative day 1(on postoperative day 1)
  • Leicester Cough Questionnaire for Measuring Chronic Cough at 3 weeks post-operation(at 3 weeks post-operation)
  • Condition of hoarseness in PACU(during in PACU, an average of 1 hour)
  • Numerical Rating Scale for cough intensity at 3 weeks post-operation(at 3 weeks post-operation)
  • Incidence of postoperative cough following lung resection at 8 weeks post-operation(at 8 weeks post-operation)
  • Leicester Cough Questionnaire for Measuring Chronic Cough at 8 weeks post-operation(at 8 weeks post-operation)
  • Numerical Rating Scale for cough intensity at 8 weeks post-operation(at 8 weeks post-operation)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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