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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03086213

Enrollment

Registered

2017-03-22

Start date

2017-03-01

Completion date

2019-09-05

Last updated

2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Solitary Pulmonary Nodule or Tuberculoma

Keywords

nonintubated uniport thoracoscopic surgery, paravertebral nerve block, intercostal nerve block, peripheral solitary pulmonary nodule

Brief 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.

Detailed 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).

Interventions

DRUGPropofol

anaesthetic

DRUGSulfentanyl

anaesthetic

DRUGDexmedetomidine

anaesthetic

DRUGLidocaine

local anaesthetics

DRUGRopivacaine

local anaesthetics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group	During the operation, an average of one hour	serum concentrations of Interleukin-6
Concentration of Cortisol at Different Point During the Operation	During the operation, an average of one hour	—

Secondary

Measure	Time frame	Description
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation	During the operation, an average of one hour	data of mean arterial pressure
Comparing the Blood Gas Analysis After the Intervention of the Each Group	During the operation, an average of one hour	data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation
Number of Participants With Puncture Related Complications	7 days	puncture related complications

Countries

China

Participant flow

Participants by arm

Arm	Count
Per Arm paravertebral nerve block and intercostal nerve block	48
Total	48

Baseline characteristics

Characteristic	Per Arm	—
Age, Continuous INB	42.0 years STANDARD_DEVIATION 13.5	—
Age, Continuous PVB	34.6 years STANDARD_DEVIATION 10.47	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male INB Female	30 Participants	—
Sex: Female, Male INB Male	18 Participants	—
Sex: Female, Male PVB Female	30 Participants	—
Sex: Female, Male PVB Male	18 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 24	0 / 24
other Total, other adverse events	0 / 24	0 / 24
serious Total, serious adverse events	2 / 24	1 / 24