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

Primary Purpose

Peripheral Solitary Pulmonary Nodule or Tuberculoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Propofol
Sulfentanyl
Dexmedetomidine
Lidocaine
Ropivacaine
Sponsored by
Shenzhen Third People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Solitary Pulmonary Nodule or Tuberculoma focused on measuring nonintubated uniport thoracoscopic surgery, paravertebral nerve block, intercostal nerve block, peripheral solitary pulmonary nodule

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • the Third People's Hospital of Shenzhen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

paravertebral nerve block group

intercostals nerve block group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
serum concentrations of Interleukin-6
Concentration of Cortisol at Different Point During the Operation

Secondary Outcome Measures

Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
data of mean arterial pressure
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
data of heart rate
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
Number of Participants With Puncture Related Complications
puncture related complications

Full Information

First Posted
March 7, 2017
Last Updated
April 27, 2020
Sponsor
Shenzhen Third People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03086213
Brief Title
Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Third People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Solitary Pulmonary Nodule or Tuberculoma
Keywords
nonintubated uniport thoracoscopic surgery, paravertebral nerve block, intercostal nerve block, peripheral solitary pulmonary nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paravertebral nerve block group
Arm Type
Experimental
Arm Description
non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace
Arm Title
intercostals nerve block group
Arm Type
Active Comparator
Arm Description
non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
anaesthetic
Intervention Type
Drug
Intervention Name(s)
Sulfentanyl
Intervention Description
anaesthetic
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
anaesthetic
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
local anaesthetics
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
local anaesthetics
Primary Outcome Measure Information:
Title
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Description
serum concentrations of Interleukin-6
Time Frame
During the operation, an average of one hour
Title
Concentration of Cortisol at Different Point During the Operation
Time Frame
During the operation, an average of one hour
Secondary Outcome Measure Information:
Title
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
Description
data of mean arterial pressure
Time Frame
During the operation, an average of one hour
Title
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
Description
data of heart rate
Time Frame
During the operation, an average of one hour
Title
Comparing the Blood Gas Analysis After the Intervention of the Each Group
Description
data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation
Time Frame
During the operation, an average of one hour
Title
Number of Participants With Puncture Related Complications
Description
puncture related complications
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
the Third People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is not a plan to make individual participant data available to other researcher.

Learn more about this trial

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

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