Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients

Peripheral Solitary Pulmonary Nodule or Tuberculoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086213
• Other study ID #: 19800911
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: September 5, 2019

Study information

• Verified date: April 2020
• Source: Shenzhen Third People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 5, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Peripheral Solitary Pulmonary Nodule or Tuberculoma
• Solitary Pulmonary Nodule

Intervention

Drug:
• Propofol
anaesthetic
• Sulfentanyl
anaesthetic
• Dexmedetomidine
anaesthetic
• Lidocaine
local anaesthetics
• Ropivacaine
local anaesthetics

Locations

Country	Name	City	State
China	the Third People's Hospital of Shenzhen	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Third People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group	serum concentrations of Interleukin-6	During the operation, an average of one hour
Primary	Concentration of Cortisol at Different Point During the Operation		During the operation, an average of one hour
Secondary	Comparing the Hemodynamics of the Intervention of the Each Group During the Operation	data of mean arterial pressure	During the operation, an average of one hour
Secondary	Comparing the Hemodynamics of the Intervention of the Each Group During the Operation	data of heart rate	During the operation, an average of one hour
Secondary	Comparing the Blood Gas Analysis After the Intervention of the Each Group	data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation	During the operation, an average of one hour
Secondary	Number of Participants With Puncture Related Complications	puncture related complications	7 days