Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Solitary Pulmonary Nodule or Tuberculoma
• Intervention / Treatment: Drug: Propofol; Drug: Sulfentanyl; Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Ropivacaine

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).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 510000
      • The Third People's Hospital of Shenzhen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shenzhen Third People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 5, 2019

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (ACTUAL): March 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: intercostal nerve block; nonintubated uniport thoracoscopic surgery; paravertebral nerve block; peripheral solitary pulmonary nodule
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Lung Neoplasms; Mycobacterium Infections; Tuberculosis; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule; Tuberculoma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Dexmedetomidine; Lidocaine; Ropivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: 19800911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is not a plan to make individual participant data available to other researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No