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临床试验/NCT03086213
NCT03086213已完成不适用

the Safety and Effectiveness of the Effects on the Perioperative Pain Control Comparing Between the Thoracic Paravertebral Nerve Block Using the Camera Guided and the Intrathoracic Intercostals Nerve Block for the Management of Nonintubated Local Regional Analgesia in Uniport Thoracoscopic Surgery for the Undetermined Solitary Nodules Patients

Shenzhen Third People's Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group

研究概览

简要总结

The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals nerve block for the management of nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined solitary nodules patients.

详细描述

Thoracoscopic minor lung resection has been the reasonable option for the diagnosis and treatment of management of the undetermined peripheral pulmonary nodules. Uniport procedure could reduce postoperative pain score, the length of hospital stay, moreover, nonintubated technique can avoid the disadvantages of conventional general anesthesia such as ventilator induced lung injury, sore throat or voice change. The nonintubated technique without tracheal intubation under spontaneous ventilation combined with uniport or single port thoracoscopic surgery has emerged as the least invasive procedure of wedge resection of peripheral pulmonary nodules, even the anatomical thoracoscopic lobectomy along with mediastinal lymph nodule dissection in case of the diagnosis of the primary lung cancer during the operation.

The initial experience of nonintubated thoracoscopic surgery included the intravenous controlled sedation and pain , thoracic epidural analgesia and thoracic vagus nerve block, due to series of adverse events of the epidural analgesia, operator was willing to perform the intrathoracic intercostal nerve block guided by camera during the operation and was considered as the simple and safety method for regional analgesia .However, the intercostal nerve block can not employ the adequate pain control ,after the surgery, the patient controlled analgesia is as usual needed.

The previous study showed that paravertebral block was the same effect on relieved pain as thoracic epidural analgesia and had the less complications such as hypotension, nausea or vomiting. With the advance in the technique of application of ultrasound, it is more interesting that using the ultrasound technique before the surgery is performed for the adequate pain control of the local regional analgesia in nonintubated surgery under spontaneous ventilation. However, ultrasound technique is difficult to have the skilled experience for the most anaesthetists and increase the related puncture complications such as hematoma, bleeding or pneumothorax. The method used study is guided by camera which is very simple and safety by avoidance of the puncture of the partial pleura or intercostal blood vessel, The investigators once used this approach for postoperative pain control under general intubation for lung cancer patients, so the investigators have had a skilled experience for achieving regional analgesia of nonintubated uniport thoracoscopic wedge resection.

So far, there has been no articles about thoracic paravertebral nerve block for regional analgesia of nonintubated thoracoscopic procedure patients. The investigators designed the study to compare the short term outcome on thoracic paravertebral nerve block in nonintubated technique with those of intercostal nerve block in uniport nonintubated video-assisted thoracoscopic surgery(VATS) as the control group.

This study will be performed at the third people's hospital of Shenzhen. A total of 48 patients will be enrolled(24 patients in each arms).

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent
  • the undetermined peripheral solitary pulmonary nodule or tuberculoma was enrolled
  • the well cardiopulmonary function
  • age between 18 and 65 years old
  • less airway secretion
  • body mass index less than 25
  • I to II grade of the American Society of Anesthesiologists
  • no metabolic diseases

排除标准

  • refusal or inability to comply with the informed consent
  • the nodule of the nature of the non small cell lung caner is excluded
  • hypovolemia, blood disorders or abnormal clotting mechanism
  • the abnormal cardiopulmonary function(the American Society of Anesthesiologists greater than 3)
  • lower airway infection,more than airway secretion
  • abnormal anatomy of the spine,the history of thoracic back surgery
  • impaired lung function(forced expiratory volume in second 1 less than predicted), or asthma uncontrolled on medications
  • constrained cardiac output such as hypertrophic cardiomyopathy, mitral stenosis or complete atrioventricular block
  • extensive pleural adhesion
  • overweight (body mass index no less than 25)
  • difficulty airway
  • chronic pain score more than 5 before the surgery
  • the history of bilateral thoracotomy

研究组 & 干预措施

paravertebral nerve block group

Experimental

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

干预措施: Propofol (Drug)

paravertebral nerve block group

Experimental

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

干预措施: Sulfentanyl (Drug)

paravertebral nerve block group

Experimental

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

干预措施: Dexmedetomidine (Drug)

paravertebral nerve block group

Experimental

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

干预措施: Lidocaine (Drug)

paravertebral nerve block group

Experimental

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

干预措施: Ropivacaine (Drug)

intercostals nerve block group

Active Comparator

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

干预措施: Propofol (Drug)

intercostals nerve block group

Active Comparator

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

干预措施: Sulfentanyl (Drug)

intercostals nerve block group

Active Comparator

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

干预措施: Dexmedetomidine (Drug)

intercostals nerve block group

Active Comparator

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

干预措施: Lidocaine (Drug)

intercostals nerve block group

Active Comparator

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group

时间窗: During the operation, an average of one hour

serum concentrations of Interleukin-6

Concentration of Cortisol at Different Point During the Operation

时间窗: During the operation, an average of one hour

次要结局

  • Number of Participants With Puncture Related Complications(7 days)
  • Comparing the Hemodynamics of the Intervention of the Each Group During the Operation(During the operation, an average of one hour)
  • Comparing the Blood Gas Analysis After the Intervention of the Each Group(During the operation, an average of one hour)

研究者

发起方
Shenzhen Third People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

xia zhaohua

Director, Head of thoracic surgical department, Principal investigator, Associate clinical professor

Shenzhen Third People's Hospital

研究点 (1)

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