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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | anaesthetic |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Concentration of Cortisol at Different Point During the Operation | During the operation, an average of one hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparing the Hemodynamics of the Intervention of the Each Group During the Operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third People's Hospital of Shenzhen | Shenzhen | Guangdong | 510000 | China |
there is not a plan to make individual participant data available to other researcher.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paravertebral Nerve Block Group | non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2020 | Apr 7, 2020 |
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| Sulfentanyl | Drug | anaesthetic |
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| Dexmedetomidine | Drug | anaesthetic |
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| Lidocaine | Drug | local anaesthetics |
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| Ropivacaine | Drug | local anaesthetics |
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data of heart rate
| During the operation, an average of one hour |
| 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 |
| Number of Participants With Puncture Related Complications | puncture related complications | 7 days |
| FG001 |
| Intercostals Nerve Block Group |
non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Per Arm | paravertebral nerve block and intercostal nerve block |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | there is two arms for the overall subjects divided into the two different regional anesthesia. | Mean | Standard Deviation | years |
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| Sex: Female, Male | there is two arms for the overall subjects of this study divided into the two different regional anesthsia | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group | serum concentrations of Interleukin-6 | Posted | Mean | Standard Deviation | pg/L | During the operation, an average of one hour |
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| Primary | Concentration of Cortisol at Different Point During the Operation | Posted | Mean | Standard Deviation | ng/mL | During the operation, an average of one hour |
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| Secondary | Comparing the Hemodynamics of the Intervention of the Each Group During the Operation | data of mean arterial pressure | Posted | Mean | Standard Deviation | mmHg | During the operation, an average of one hour |
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| Secondary | Comparing the Hemodynamics of the Intervention of the Each Group During the Operation | data of heart rate | Posted | Mean | Standard Deviation | bpm | During the operation, an average of one hour |
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| 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 | Posted | Mean | Standard Deviation | cmH2O | During the operation, an average of one hour |
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| Secondary | Number of Participants With Puncture Related Complications | puncture related complications | Posted | Count of Participants | Participants | 7 days |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paravertebral Nerve Block Group | non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics | 0 | 24 | 2 | 24 | 0 | 24 |
| EG001 | Intercostals Nerve Block Group | non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics | 0 | 24 | 1 | 24 | 0 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding related to the puncture in the pleural cavity | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thoracic surgical department | Shenzhen Third People,s Hospital | 13823135410 | daoren_000113@126.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 7, 2020 | Apr 7, 2020 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2020 | Apr 7, 2020 | ICF_002.pdf |
| ID | Term |
|---|---|
| D014375 | Tuberculoma |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D017409 | Sufentanil |
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| INB |
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| Interleukin-6 T2 |
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| Interleukin-6 T3 |
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the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.
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