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

• Sponsor: Shenzhen Third People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03086213
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual 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: Mar 1, 2017
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Sep 5, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group [During the operation, an average of one hour]

   serum concentrations of Interleukin-6

2. Concentration of Cortisol at Different Point During the Operation [During the operation, an average of one hour]

Secondary Outcome Measures

1. Comparing the Hemodynamics of the Intervention of the Each Group During the Operation [During the operation, an average of one hour]

   data of mean arterial pressure

2. Comparing the Hemodynamics of the Intervention of the Each Group During the Operation [During the operation, an average of one hour]

   data of heart rate

3. Comparing the Blood Gas Analysis After the Intervention of the Each Group [During the operation, an average of one hour]

   data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation

4. Number of Participants With Puncture Related Complications [7 days]

   puncture related complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Third People's Hospital of Shenzhen	Shenzhen	Guangdong	China	510000

Sponsors and Collaborators

• Shenzhen Third People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 7, 2020
• Study Protocol - Apr 7, 2020
• Informed Consent Form - Apr 7, 2020

More Information

Publications

None provided.

• Responsible Party: xia zhaohua, Director, Head of thoracic surgical department, Principal investigator, Associate clinical professor, Shenzhen Third People's Hospital
• ClinicalTrials.gov Identifier: NCT03086213
• Other Study ID Numbers: 19800911
• First Posted: Mar 22, 2017
• Last Update Posted: May 7, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by xia zhaohua, Director, Head of thoracic surgical department, Principal investigator, Associate clinical professor, Shenzhen Third People's Hospital: nonintubated uniport thoracoscopic surgery; paravertebral nerve block; intercostal nerve block; peripheral solitary pulmonary nodule
• Additional relevant MeSH terms: Tuberculoma; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule; Lidocaine; Sufentanil; Dexmedetomidine; Dsuvia; Ropivacaine; Propofol

Study Results

Participant Flow

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Period Title: Overall Study
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Per Arm
Arm/Group Description	paravertebral nerve block and intercostal nerve block
Overall Participants	48
Age (years) [Mean (Standard Deviation) ]
PVB	34.6 (10.47)
INB	42.0 (13.5)
Sex: Female, Male (Count of Participants)
Female	30 62.5%
Male	18 37.5%
Female	30 62.5%
Male	18 37.5%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Description	serum concentrations of Interleukin-6
Time Frame	During the operation, an average of one hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Measure Participants	24	24
Interleukin-6 T0	33 (8)	35 (8)
Interleukin-6 T1	39 (10)	42 (9)
Interleukin-6 T2	44 (9)	53 (11)
Interleukin-6 T3	47 (9)	54 (13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paravertebral Nerve Block Group, Intercostals Nerve Block Group
	Comments	null hypothesis
	Type of Statistical Test	Non-Inferiority
	Comments	the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.
Statistical Test of Hypothesis	p-Value	0.025
	Comments	whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
	Method	t-test, 2 sided
	Comments	degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10
	Confidence Interval	(2-Sided) 95%; 5 to 95
	Parameter Dispersion	Type: Standard Deviation; Value: 0.025
	Estimation Comments	Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk

2. Primary Outcome

Title	Concentration of Cortisol at Different Point During the Operation
Time Frame	During the operation, an average of one hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Measure Participants	24	24
During the operation, 0m	120 (31)	125 (33)
During the operation, 15m	208 (49)	221 (66)
During the operation, 30m	258 (69)	290 (71)
During the operation, 60m	267 (77)	318 (74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intercostals Nerve Block Group
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments	During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.
	Method	t-test, 2 sided
	Comments	degrees of freedom is defined as sample size subtraction one.

3. Secondary Outcome

Title	Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
Description	data of mean arterial pressure
Time Frame	During the operation, an average of one hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Measure Participants	24	24
mean arterial pressure T0	79 (7)	80 (8)
mean arterial pressure T1	85 (8)	86 (8)
mean arterial pressure T2	72 (9)	85 (7)
mean arterial pressure T3	78 (6)	80 (8)

4. Secondary Outcome

Title	Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
Description	data of heart rate
Time Frame	During the operation, an average of one hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Measure Participants	24	24
heart rate T0	78 (7)	79 (7)
heart rate T1	84 (6)	85 (7)
heart rate T2	81 (8)	92 (9)
heart rate T3	78 (7)	80 (5)

5. Secondary Outcome

Title	Comparing the Blood Gas Analysis After the Intervention of the Each Group
Description	data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation
Time Frame	During the operation, an average of one hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Measure Participants	24	24
arterial partial pressure of oxygen(PaO2)	95.2 (1.8)	96.2 (1.8)
arterial partial pressure of PaC	51.1 (11.1)	47.3 (9.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intercostals Nerve Block Group
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments	During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments	Degree of freedom is defined as sample size subtraction one.

6. Secondary Outcome

Title	Number of Participants With Puncture Related Complications
Description	puncture related complications
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paravertebral Nerve Block Group	Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics	non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
Measure Participants	20	20
hematoma	2 4.2%	3 NaN
pain of punture position	2 4.2%	2 NaN

Adverse Events

Time Frame	1 year
Arm/Group Title	Paravertebral Nerve Block Group		Intercostals Nerve Block Group
Arm/Group Description	non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics		non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Propofol: anaesthetic Sulfentanyl: anaesthetic Dexmedetomidine: anaesthetic Lidocaine: local anaesthetics Ropivacaine: local anaesthetics
All Cause Mortality
	Paravertebral Nerve Block Group		Intercostals Nerve Block Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Paravertebral Nerve Block Group		Intercostals Nerve Block Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/24 (8.3%)		1/24 (4.2%)
Injury, poisoning and procedural complications
bleeding related to the puncture in the pleural cavity	2/24 (8.3%)	2	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	Paravertebral Nerve Block Group		Intercostals Nerve Block Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.