Clinical trial NCT03086213
Conditions: Peripheral Solitary Pulmonary Nodule or Tuberculoma
Keywords: nonintubated uniport thoracoscopic surgery paravertebral nerve block intercostal nerve block peripheral solitary pulmonary nodule
Sponsor: Shenzhen Third People's Hospital
Start date: 2017-03-01; Completion date: 2019-09-05
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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).

Arms: arm 1: non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace arm 2: non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace
Interventions: intervention 1: Propofol intervention 2: Sulfentanyl intervention 3: Dexmedetomidine intervention 4: Lidocaine intervention 5: Ropivacaine
Intervention descriptions: intervention 1: anaesthetic intervention 2: anaesthetic intervention 3: anaesthetic intervention 4: local anaesthetics intervention 5: local anaesthetics

Protocol documents:
ICF_002.pdf: 
Official title:comparative study of nonintubated uniport 
thoracoscopic surgery using thoracic paravertebral nerve block 
versus intercostal nerve block for peripheral solitary pulmonary 
nodule patients 
NCT number:03086213 
Document date:April 7,2020 
 
 
Informed consent form 
Updated:April 7,2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Purpose of the study 
The purpose of this study is to compare with the safety and efficient 
on paravertebral nerve block for the nonintubated uniport 
thoracoscopic surgery for patients with peripheral solitary 
pulmonarynodules  
Who sponsor this study? 
This study is sponsored by the thoracic surgical department of 
Shenzhenthird people’shospital. Adverse effects during the study 
There is conventionalprocedure of regional anesthesia such as 
paravertebral nerve block guided by ultrasound or intercostal nerve 
block by thoracoscopy ,so it is determined the total protocols of this 
study is safe for the eligible subjects.However,there is somewhat 
uncomfortable for the medical serve during the operation. 
The amount of drawing blood for every subject is approximately 
10ml.  
Can you delete the study at any time? 
Ok,if you want to exit the study due to any reason,you can do that . 
What is benefical for the eligiable subjects? 
There is 100 RMB of additional fee for the subjects of the study. he 
information of the subjects for admitting the study is 
confidentiality,so you can not afraid about the reveal yourself 
privacy. 


Who can you communicate with? 
If you have any question,you can communicate with the principal of 
this study,whose mobleis 13823135410 
 
Patient signature 
date  
 
Doctor  
signature at 

Prot_001.pdf: 
Official title:comparative study of nonintubated uniport thoracoscopic surgery  
using thoracic paravertebral nerve block versus intercostal nerve block for  
peripheral solitary pulmonary nodule patients  
 
NCT number:03086213  
Document date:April 7,2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol study 
 
Nonintubated spontaneous breathing anesthesia preparation and implementation  
The same protocol for nonintubated, spontaneous breathing anesthesia was used  
for both groups of patients, as described previously [9]. All patients were  
administered intravenous propofol (target-controlled infusion, 2–3.5 µg/mL) and  
sufentanil (0.1 µg/mL). When the bispectral index (BIS) dropped to 60, a laryngeal  
mask was immediately placed and connected to the breathing circuit. Before making  
the skin incision, all patients were sedated with administration of intravenous  
propofol (1.5–2 µg/mL) by using the method of total venous anesthesia (TCI),  
remifentanil (0.05–0.08 µg/kg/min), and dexmedetomidine (0.5–1 µg/kg/h) to  
achieve a BIS of 45–60. During the procedure, the patients were able to breathe  
spontaneously through the laryngeal mask to maintain the oxygen saturation at  
levels greater than 90%.  
Early-stage preparation for uniportal minor lung resection technique  
The surgical procedure for nonintubated spontaneous breathing uniportal VATS  
for patients with a solitary peripheral lung nodule has previously been described in  
detail[9]. A 3-cm-long incision was made at the level of the fifth or sixth intercostal  
space and INB and surface anesthesia were induced by administration of 1%  
lidocaine (2 mL). Visceral pleura was anesthetized using 2% lidocaine (5 mL). The  
intrathoracic vagus nerve was blocked by the injection of 0.5% ropivacaine combined  
with 2% lidocaine (2.5 mL) at a point adjacent to the vagus nerve as well as at the  
level of the aortopulmonary window on the left side and at the level of the lower  
trachea on the right side. The blockade of the vagus nerve reduced the cough reflex  
for several hours, which allowed sufficient time to perform the minor wedge lung  
resection.  
Paravertebral nerve block or intercostal nerve block based on the regional  
anesthesia for nonintubated anesthesia  
For PVB group, the single port was established along the upper edge of the  
spinous process of the thoracic vertebral body at the T4 thoracic interspace at a 
point that was equidistant from the upper and lower intercostal spaces. Using the  
epidural needle (Tuohy 18G, Braun, Melsungen, Germany), the injection was made 3  
cm lateral to the midline. The paravertebral space was entered by advancing the  
epidural needle over the upper edge of the transverse process. The path of the  
epidural needle and the entrance of the needle tip into the thoracic paravertebral  
space were continuously monitored by thoracoscopy. Then, an injection of 1%  
lidocaine (10 mL) combined with 0.5% ropivacaine (10 mL) into the paravertebral  
space was administered, causing the uplifting of the parietal pleura.  
For the INB group, the intrathoracic INB at the T3, T4, or T5 intercostal space was  
performed under thoracoscopic guidance by the administration of 1% lidocaine (10  
mL) and 0.5% ropacaine (10 mL) using a 25-gauge top-winged infusion needle.  
Uniportal minor lung resection  
Through the single-port incision, the presence of the lung nodules was confirmed  
by manual palpation or instruments or by preoperative CT-guided localization.  


Wedge lung resection was performed by using an articulating endoscopic linear  
cutter (Echelon 45 Endopath stapler; Ethicon Endo surgery Corp, OH, USA), with 4.5  
cm or 6.0 cm cartridges. The regular specimen collection bags were used for the  
extraction of the resected specimens. The resected lung parenchyma was forwarded  
to the pathology department for confirmation of the histological nature of the frozen  
specimens. If pathologic examination of the frozen specimen confirmed that the  
lesion was a benign tumor, such as tuberculoma, fungal infection, or inflammatory  
pseudotumor, the current surgical margin was considered to be reasonable.  
Air leakage monitor and incision closure without the chest tube drainage  
At the end of the surgery, the patients were checked for air leakage by  
observation during the gradual inflation of the collapsed lung. The operated lung was  
washed with warm saline, and manual continuous-assisted mask ventilation was  
applied until the collapsed lung tissue expanded to its -full volume.  
The re-expansion of the lung, performed under thoracoscopic guidance, was  
achieved by the insertion of a suction catheter connected to a negative-pressure 
suction device. When lung re-expansion was visually confirmed, the suction catheter  
was removed and the uniportal incision was rapidly closed with continuous sutures.  
Intravenous morphine anesthesia pump postoperatively  
The postoperative protocol was the same for both the groups. All patients were  
allowed to remain in the recovery room for 1 to 2 hours after the operation before  
being transferred to the general ward. Postoperative patient-controlled analgesia  
with intravenous morphine was administered with the following conditions: 150 mg  
morphine in 150 ml NS, 1 mg/mL, only bolus dose; 1 mg per bolus; lockout interval,  
10 min) was administered.  
Ramsay sedation scale  
Sedation was assessed by Ramsay sedation scale including1 score being anxious and  
agitated or restless or both,2 scores being cooperative, oritented and tranquil,3  
scores being responding to commands only,4 scores being brisk response to light  
glabellar tap or loud auditory stimulus,5 scores being sluggish response to light  
glabellar tap or loud auditory stimulus.  
Chest radiography and thoracic ultrasonography during the early postoperative  
stage  
In both the groups, chest radiography and thoracic ultrasonography were  
performed 4 hours after the operation, i.e., during the early postoperative stage, in  
order to assess the degree of pneumothorax or pleural effusion. If pneumothorax  
was present or if the patient had moderate or severe pleural effusion, leading to  
clinical deterioration of the patient’s respiratory status, a chest tube was implanted  
for drainage.  
Discharge and follow-up for the patients  
Patients in both groups were considered fit for discharge if severe pneumothorax  
was absent and/or pleural effusion was moderate, as assessed by chest radiography  
or ultrasonography. Follow-ups of all the enrolled patients were conducted in the  
outpatient department at 7 days and 1 month after the operation; the patients also  
underwent chest radiography at the time of follow-up. 

SAP_000.pdf: 
Official title:comparative study of nonintubated uniport
thoracoscopic surgery using thoracic paravertebral nerve
block versus intercostal nerve block for peripheral solitary
pulmonary nodule patients
NCT number:03086213
Document date:April 7,2020
Statistical analysis plan
Updated:April 7,2020


The evaluation of the pain scale of the enrolled subjects was
performed using the visual analog score (VAS) and graded
between 0 (no pain) and 10 (severe pain) after the operation.
The study phase lasted 48 hours, and the data collection was
performed by a person not involved in the study (ward nurse
assigned beforehand) and the VAS was entered in a case report
form. The following parameters were assessed: (1) quantity of
intravenous drugs administered such as propofol, remifentanil,
and dexmedetomidine; (2) adverse events related to puncture,
including bleeding; hematoma; nerve injury; postoperative pain
scores at 1, 6, 24, and 48 hours; requirement for rescue
analgesia (morphine); adverse effects of the analgesia
procedure, including respiratory depression, pneumothorax,
cardiotoxicity, sedation, urinary retention, nausea, vomiting,
and pruritus. Descriptive statistics are shown as means ± SD for
continuous data and as number and percentage for categorical
data. The two-sample t-test was employed for statistical
analysis of continuous variables and Fisher exact test was used
for the statistical analysis of categorical variables such as sex.
All data analyses were performed using SPSS 22.0 (Chicago, IL)
and all statistical tests were two-sided. Statistical significance
was defined as a p value of less than 0.05