Trial Outcomes & Findings for Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients (NCT NCT03086213)
NCT ID: NCT03086213
Last Updated: 2020-05-07
Results Overview
serum concentrations of Interleukin-6
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
During the operation, an average of one hour
Results posted on
2020-05-07
Participant Flow
Participant milestones
| Measure |
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
Propofol: anaesthetic
Sulfentanyl: anaesthetic
Dexmedetomidine: anaesthetic
Lidocaine: local anaesthetics
Ropivacaine: local anaesthetics
|
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
Propofol: anaesthetic
Sulfentanyl: anaesthetic
Dexmedetomidine: anaesthetic
Lidocaine: local anaesthetics
Ropivacaine: local anaesthetics
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
there is two arms for the overall subjects divided into the two different regional anesthesia.
Baseline characteristics by cohort
| Measure |
Per Arm
n=48 Participants
paravertebral nerve block and intercostal nerve block
|
|---|---|
|
Age, Continuous
PVB
|
34.6 years
STANDARD_DEVIATION 10.47 • n=24 Participants • there is two arms for the overall subjects divided into the two different regional anesthesia.
|
|
Age, Continuous
INB
|
42.0 years
STANDARD_DEVIATION 13.5 • n=24 Participants • there is two arms for the overall subjects divided into the two different regional anesthesia.
|
|
Sex: Female, Male
PVB · Female
|
30 Participants
n=48 Participants • there is two arms for the overall subjects of this study divided into the two different regional anesthsia
|
|
Sex: Female, Male
PVB · Male
|
18 Participants
n=48 Participants • there is two arms for the overall subjects of this study divided into the two different regional anesthsia
|
|
Sex: Female, Male
INB · Female
|
30 Participants
n=48 Participants • there is two arms for the overall subjects of this study divided into the two different regional anesthsia
|
|
Sex: Female, Male
INB · Male
|
18 Participants
n=48 Participants • there is two arms for the overall subjects of this study divided into the two different regional anesthsia
|
PRIMARY outcome
Timeframe: During the operation, an average of one hourserum concentrations of Interleukin-6
Outcome measures
| Measure |
Paravertebral Nerve Block Group
n=24 Participants
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
|
Intercostals Nerve Block Group
n=24 Participants
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
|
|---|---|---|
|
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Interleukin-6 T0
|
33 pg/L
Standard Deviation 8
|
35 pg/L
Standard Deviation 8
|
|
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Interleukin-6 T1
|
39 pg/L
Standard Deviation 10
|
42 pg/L
Standard Deviation 9
|
|
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Interleukin-6 T2
|
44 pg/L
Standard Deviation 9
|
53 pg/L
Standard Deviation 11
|
|
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Interleukin-6 T3
|
47 pg/L
Standard Deviation 9
|
54 pg/L
Standard Deviation 13
|
PRIMARY outcome
Timeframe: During the operation, an average of one hourOutcome measures
| Measure |
Paravertebral Nerve Block Group
n=24 Participants
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
|
Intercostals Nerve Block Group
n=24 Participants
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
|
|---|---|---|
|
Concentration of Cortisol at Different Point During the Operation
During the operation, 0m
|
120 ng/mL
Standard Deviation 31
|
125 ng/mL
Standard Deviation 33
|
|
Concentration of Cortisol at Different Point During the Operation
During the operation, 15m
|
208 ng/mL
Standard Deviation 49
|
221 ng/mL
Standard Deviation 66
|
|
Concentration of Cortisol at Different Point During the Operation
During the operation, 30m
|
258 ng/mL
Standard Deviation 69
|
290 ng/mL
Standard Deviation 71
|
|
Concentration of Cortisol at Different Point During the Operation
During the operation, 60m
|
267 ng/mL
Standard Deviation 77
|
318 ng/mL
Standard Deviation 74
|
SECONDARY outcome
Timeframe: During the operation, an average of one hourdata of mean arterial pressure
Outcome measures
| Measure |
Paravertebral Nerve Block Group
n=24 Participants
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
|
Intercostals Nerve Block Group
n=24 Participants
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
|
|---|---|---|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
mean arterial pressure T2
|
72 mmHg
Standard Deviation 9
|
85 mmHg
Standard Deviation 7
|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
mean arterial pressure T0
|
79 mmHg
Standard Deviation 7
|
80 mmHg
Standard Deviation 8
|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
mean arterial pressure T1
|
85 mmHg
Standard Deviation 8
|
86 mmHg
Standard Deviation 8
|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
mean arterial pressure T3
|
78 mmHg
Standard Deviation 6
|
80 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: During the operation, an average of one hourdata of heart rate
Outcome measures
| Measure |
Paravertebral Nerve Block Group
n=24 Participants
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
|
Intercostals Nerve Block Group
n=24 Participants
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
|
|---|---|---|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
heart rate T0
|
78 bpm
Standard Deviation 7
|
79 bpm
Standard Deviation 7
|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
heart rate T1
|
84 bpm
Standard Deviation 6
|
85 bpm
Standard Deviation 7
|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
heart rate T2
|
81 bpm
Standard Deviation 8
|
92 bpm
Standard Deviation 9
|
|
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
heart rate T3
|
78 bpm
Standard Deviation 7
|
80 bpm
Standard Deviation 5
|
SECONDARY outcome
Timeframe: During the operation, an average of one hourdata of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation
Outcome measures
| Measure |
Paravertebral Nerve Block Group
n=24 Participants
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
|
Intercostals Nerve Block Group
n=24 Participants
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
|
|---|---|---|
|
Comparing the Blood Gas Analysis After the Intervention of the Each Group
arterial partial pressure of oxygen(PaO2)
|
95.2 cmH2O
Standard Deviation 1.8
|
96.2 cmH2O
Standard Deviation 1.8
|
|
Comparing the Blood Gas Analysis After the Intervention of the Each Group
arterial partial pressure of PaC
|
51.1 cmH2O
Standard Deviation 11.1
|
47.3 cmH2O
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 7 dayspuncture related complications
Outcome measures
| Measure |
Paravertebral Nerve Block Group
n=20 Participants
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
|
Intercostals Nerve Block Group
n=20 Participants
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
|
|---|---|---|
|
Number of Participants With Puncture Related Complications
hematoma
|
2 Participants
|
3 Participants
|
|
Number of Participants With Puncture Related Complications
pain of punture position
|
2 Participants
|
2 Participants
|
Adverse Events
Paravertebral Nerve Block Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Intercostals Nerve Block Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paravertebral Nerve Block Group
n=24 participants at risk
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
|
Intercostals Nerve Block Group
n=24 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
bleeding related to the puncture in the pleural cavity
|
8.3%
2/24 • Number of events 2 • 1 year
|
4.2%
1/24 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Thoracic surgical department
Shenzhen Third People,s Hospital
Phone: 13823135410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place