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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

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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
Sponsor:
Information provided by (Responsible Party):
xia zhaohua, Shenzhen Third People's Hospital

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.

Condition or disease Intervention/treatment Phase
Peripheral Solitary Pulmonary Nodule or Tuberculoma Drug: Propofol Drug: Sulfentanyl Drug: Dexmedetomidine Drug: Lidocaine Drug: Ropivacaine Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Drug: Propofol
anaesthetic

Drug: Sulfentanyl
anaesthetic

Drug: Dexmedetomidine
anaesthetic

Drug: Lidocaine
local anaesthetics

Drug: Ropivacaine
local anaesthetics

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
Drug: Propofol
anaesthetic

Drug: Sulfentanyl
anaesthetic

Drug: Dexmedetomidine
anaesthetic

Drug: Lidocaine
local anaesthetics

Drug: Ropivacaine
local anaesthetics




Primary Outcome Measures :
  1. comparing the stress response marker during the operation after the intervention of the each group [ Time Frame: during the operation ]
    serum concentration of Cortisol

  2. 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


Secondary Outcome Measures :
  1. comparing the visual pain score of the each group after the surgery respectively [ Time Frame: 7 days ]
    in state of rest and in mobilization

  2. comparing the hemodynamics of the intervention of the each group during the operation [ Time Frame: during the operation ]
    data of mean arterial pressure

  3. comparing the hemodynamics of the intervention of the each group during the operation [ Time Frame: during the operation ]
    data of heart rate

  4. 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

  5. comparing the complications after the intervention of the each group [ Time Frame: 7 days ]
    puncture related complications


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Zhaohua Xia, MD 08613823135410 daoren_000113@126.com

Locations
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China, Guangdong
the Third People's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China, 510000
Contact: Zhaohua Xia, MD    08613823135410    daoren_000113@126.com   
Sponsors and Collaborators
Shenzhen Third People's Hospital

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Responsible Party: xia zhaohua, Director, Head of thoracic surgical department, Principal investigator, Associate clinical professor, Shenzhen Third People's Hospital
ClinicalTrials.gov Identifier: NCT03086213     History of Changes
Other Study ID Numbers: 19800911
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is not a plan to make individual participant data available to other researcher.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by xia zhaohua, Shenzhen Third People's Hospital:
nonintubated uniport thoracoscopic surgery
paravertebral nerve block
intercostal nerve block
peripheral solitary pulmonary nodule
Additional relevant MeSH terms:
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Tuberculoma
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Sufentanil
Dexmedetomidine
Ropivacaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic