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
Phase: NA
Conditions: Peripheral Solitary Pulmonary Nodule or Tuberculoma
Sponsor: Shenzhen Third People's Hospital

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.