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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|ClinicalTrials.gov Identifier: NCT03086213|
Recruitment Status : Unknown
Verified March 2017 by xia zhaohua, Shenzhen Third People's Hospital.
Recruitment status was: Recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Solitary Pulmonary Nodule or Tuberculoma||Drug: Propofol Drug: Sulfentanyl Drug: Dexmedetomidine Drug: Lidocaine Drug: Ropivacaine||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||March 30, 2018|
Experimental: 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
Active Comparator: 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
- comparing the stress response marker during the operation after the intervention of the each group [ Time Frame: during the operation ]serum concentration of Cortisol
- comparing the inflammatory markers during the operation after the intervention of the each group [ Time Frame: during the operation ]serum concentrations of Tumor necrosis factor-α and Interleukin-6
- comparing the visual pain score of the each group after the surgery respectively [ Time Frame: 7 days ]in state of rest and in mobilization
- comparing the hemodynamics of the intervention of the each group during the operation [ Time Frame: during the operation ]data of mean arterial pressure
- comparing the hemodynamics of the intervention of the each group during the operation [ Time Frame: during the operation ]data of heart rate
- comparing the blood gas analysis after the intervention of the each group [ Time Frame: during the operation ]data of arterial partial pressure of oxygen(PaO2) and PaCO2
- comparing the complications after the intervention of the each group [ Time Frame: 7 days ]puncture related complications
- comparing the overall consumption amount of the intravenous drug dosage after the intervention of the each group [ Time Frame: during the operation ]the overall consumption amount of propofol,sulfentanyl and dexmedetomidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086213
|Contact: Zhaohua Xia, MDemail@example.com|
|the Third People's Hospital of Shenzhen||Recruiting|
|Shenzhen, Guangdong, China, 510000|
|Contact: Zhaohua Xia, MD 08613823135410 firstname.lastname@example.org|