Trial Outcomes & Findings for Transversus Abdominis Plane Block on Stress Response (NCT NCT03035916)
NCT ID: NCT03035916
Last Updated: 2018-01-23
Results Overview
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
up to 48h after surgery
Results posted on
2018-01-23
Participant Flow
According to the analysis by PASS 11.0, at lease 25 participants each arm were needed.Taking into account the withdrawal of patients in the middle of the study, each group were more than a few included
Participant milestones
| Measure |
Transversus Abdominis Plane Block
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Transversus Abdominis Plane Block
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Overall Study
Puncture failed
|
0
|
2
|
0
|
Baseline Characteristics
Transversus Abdominis Plane Block on Stress Response
Baseline characteristics by cohort
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Continuous
|
56.75 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
58.60 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
60.20 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
59.18 years
STANDARD_DEVIATION 9.02 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
31 participants
n=5 Participants
|
89 participants
n=4 Participants
|
|
ASA physical status
I
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
ASA physical status
II
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
ASA physical status
III
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 48h after surgeryVenous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
0 hr after surgery
|
170.2 pg/ml
Standard Deviation 33.4
|
165.5 pg/ml
Standard Deviation 36.6
|
177.9 pg/ml
Standard Deviation 43.2
|
|
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
Baseline
|
145.6 pg/ml
Standard Deviation 25.8
|
150.9 pg/ml
Standard Deviation 33.2
|
153.1 pg/ml
Standard Deviation 35.2
|
|
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
6 hr after surgery
|
172.3 pg/ml
Standard Deviation 32.7
|
163.2 pg/ml
Standard Deviation 32.4
|
215.5 pg/ml
Standard Deviation 50.3
|
|
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
24 hr after surgery
|
150.5 pg/ml
Standard Deviation 30.9
|
155.8 pg/ml
Standard Deviation 25.3
|
175.4 pg/ml
Standard Deviation 40.2
|
|
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
48 hr after surgery
|
135.7 pg/ml
Standard Deviation 29.8
|
140.6 pg/ml
Standard Deviation 24.8
|
165.2 pg/ml
Standard Deviation 32.7
|
PRIMARY outcome
Timeframe: up to 48h after surgeryVenous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Physiological Parameters: Plasma Concentration of Epinephrine (E)
Baseline
|
33.2 pg/ml
Standard Deviation 6
|
35 pg/ml
Standard Deviation 5.4
|
34.4 pg/ml
Standard Deviation 6.1
|
|
Physiological Parameters: Plasma Concentration of Epinephrine (E)
6 hr after surgery
|
45.3 pg/ml
Standard Deviation 8.2
|
46.4 pg/ml
Standard Deviation 7.5
|
52.3 pg/ml
Standard Deviation 8.1
|
|
Physiological Parameters: Plasma Concentration of Epinephrine (E)
0 hr after surgery
|
41.5 pg/ml
Standard Deviation 6.6
|
40.5 pg/ml
Standard Deviation 7.2
|
42.2 pg/ml
Standard Deviation 7
|
|
Physiological Parameters: Plasma Concentration of Epinephrine (E)
24 hr after surgery
|
44.5 pg/ml
Standard Deviation 7
|
41.8 pg/ml
Standard Deviation 6.2
|
59.1 pg/ml
Standard Deviation 8.5
|
|
Physiological Parameters: Plasma Concentration of Epinephrine (E)
48 hr after surgery
|
40.6 pg/ml
Standard Deviation 6.3
|
39.3 pg/ml
Standard Deviation 5.2
|
48.7 pg/ml
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: up to 48h after surgeryVenous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
0 hr after surgery
|
430.4 mmol/L
Standard Deviation 152.1
|
395.2 mmol/L
Standard Deviation 133.4
|
516.1 mmol/L
Standard Deviation 162.3
|
|
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
Baseline
|
273.3 mmol/L
Standard Deviation 93
|
262.4 mmol/L
Standard Deviation 101.5
|
286.3 mmol/L
Standard Deviation 106.6
|
|
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
6 hr after surgery
|
519.2 mmol/L
Standard Deviation 156.6
|
464.2 mmol/L
Standard Deviation 155.8
|
698.3 mmol/L
Standard Deviation 188.1
|
|
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
24 hr after surgery
|
439 mmol/L
Standard Deviation 116
|
388.1 mmol/L
Standard Deviation 121.2
|
713.8 mmol/L
Standard Deviation 190
|
|
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
48 hr after surgery
|
320.6 mmol/L
Standard Deviation 112.3
|
302.8 mmol/L
Standard Deviation 112.4
|
452.4 mmol/L
Standard Deviation 165.3
|
PRIMARY outcome
Timeframe: up to 48h after surgeryWhen venous blood are collected, glucose levels are measured immediately by Glucometer.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Physiological Parameters: Plasma Concentration of Glucose (Glu)
0 hr after surgery
|
8.2 mmol/L
Standard Deviation 1.2
|
7.7 mmol/L
Standard Deviation 0.9
|
10.5 mmol/L
Standard Deviation 1.5
|
|
Physiological Parameters: Plasma Concentration of Glucose (Glu)
6 hr after surgery
|
7.5 mmol/L
Standard Deviation 1
|
7 mmol/L
Standard Deviation 0.9
|
10.8 mmol/L
Standard Deviation 1.9
|
|
Physiological Parameters: Plasma Concentration of Glucose (Glu)
Baseline
|
5 mmol/L
Standard Deviation 0.5
|
5.2 mmol/L
Standard Deviation 0.5
|
5.5 mmol/L
Standard Deviation 0.4
|
|
Physiological Parameters: Plasma Concentration of Glucose (Glu)
24 hr after surgery
|
6.5 mmol/L
Standard Deviation 0.8
|
6.3 mmol/L
Standard Deviation 0.7
|
8.6 mmol/L
Standard Deviation 1.5
|
|
Physiological Parameters: Plasma Concentration of Glucose (Glu)
48 hr after surgery
|
5.5 mmol/L
Standard Deviation 0.4
|
5.2 mmol/L
Standard Deviation 0.5
|
5.8 mmol/L
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: up to 48h after surgeryContinuous monitoring of heart rate to 48 hours after surgery.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Hemodynamic Parameters: Heart Rate.
Intubation
|
88.4 bpm
Standard Deviation 11.5
|
87 bpm
Standard Deviation 13
|
92 bpm
Standard Deviation 13.5
|
|
Hemodynamic Parameters: Heart Rate.
Incision
|
80 bpm
Standard Deviation 11.4
|
78 bpm
Standard Deviation 11.5
|
95.7 bpm
Standard Deviation 13.3
|
|
Hemodynamic Parameters: Heart Rate.
Baseline
|
75.4 bpm
Standard Deviation 12.5
|
77.1 bpm
Standard Deviation 11.1
|
76.4 bpm
Standard Deviation 12
|
|
Hemodynamic Parameters: Heart Rate.
Before induction
|
74.8 bpm
Standard Deviation 10.9
|
70 bpm
Standard Deviation 12.2
|
76 bpm
Standard Deviation 11
|
|
Hemodynamic Parameters: Heart Rate.
Induction
|
71.1 bpm
Standard Deviation 10.8
|
63.1 bpm
Standard Deviation 10.3
|
71.7 bpm
Standard Deviation 10.2
|
|
Hemodynamic Parameters: Heart Rate.
Extubation
|
82 bpm
Standard Deviation 13.5
|
80 bpm
Standard Deviation 13
|
85 bpm
Standard Deviation 15
|
|
Hemodynamic Parameters: Heart Rate.
6 hr after surgery
|
77 bpm
Standard Deviation 10.5
|
75 bpm
Standard Deviation 10
|
79 bpm
Standard Deviation 12
|
|
Hemodynamic Parameters: Heart Rate.
24 hr after surgery
|
75 bpm
Standard Deviation 10.9
|
74 bpm
Standard Deviation 11
|
81.3 bpm
Standard Deviation 10.8
|
|
Hemodynamic Parameters: Heart Rate.
48 hr after surgery
|
75.8 bpm
Standard Deviation 10.3
|
75 bpm
Standard Deviation 10.5
|
79.5 bpm
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: up to 48h after surgeryContinuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Baseline
|
87 mmHg
Standard Deviation 12.5
|
88.5 mmHg
Standard Deviation 11
|
86 mmHg
Standard Deviation 12
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Before induction
|
90 mmHg
Standard Deviation 13
|
80 mmHg
Standard Deviation 12
|
87 mmHg
Standard Deviation 13
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Induction
|
81 mmHg
Standard Deviation 10.5
|
73 mmHg
Standard Deviation 12
|
80 mmHg
Standard Deviation 13
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Intubation
|
93 mmHg
Standard Deviation 13.5
|
90 mmHg
Standard Deviation 15
|
94 mmHg
Standard Deviation 15.5
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Incision
|
85 mmHg
Standard Deviation 12
|
84 mmHg
Standard Deviation 11.5
|
98 mmHg
Standard Deviation 15
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Extubation
|
88 mmHg
Standard Deviation 13.5
|
90 mmHg
Standard Deviation 13
|
95 mmHg
Standard Deviation 15
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
6 hr after surgery
|
89 mmHg
Standard Deviation 10.5
|
86 mmHg
Standard Deviation 10
|
93 mmHg
Standard Deviation 12
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
24 hr after surgery
|
88 mmHg
Standard Deviation 12.5
|
84 mmHg
Standard Deviation 11
|
90 mmHg
Standard Deviation 14
|
|
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
48 hr after surgery
|
89 mmHg
Standard Deviation 12
|
85 mmHg
Standard Deviation 10.5
|
90 mmHg
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: during operationIntraoperative superaddition of sufentanil was measured.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Anesthetics Consumption: Sufentanil Consumption
|
4.3 ug
Standard Deviation 1.5
|
3.6 ug
Standard Deviation 1.2
|
10.2 ug
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 1hr, 6hr, 12hr, 24hr, and 48hr after surgeryPain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Questionnaire: Pain Scores at Rest
1 hr
|
2.2 units on a scale
Standard Deviation 0.7
|
1.8 units on a scale
Standard Deviation 1.0
|
2.7 units on a scale
Standard Deviation 0.6
|
|
Questionnaire: Pain Scores at Rest
6 hr
|
2.2 units on a scale
Standard Deviation 0.9
|
1.9 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 1.0
|
|
Questionnaire: Pain Scores at Rest
12 hr
|
2.0 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.7
|
2.8 units on a scale
Standard Deviation 1.0
|
|
Questionnaire: Pain Scores at Rest
24 hr
|
2.2 units on a scale
Standard Deviation 0.6
|
1.3 units on a scale
Standard Deviation 0.6
|
2.7 units on a scale
Standard Deviation 1.0
|
|
Questionnaire: Pain Scores at Rest
48 hr
|
1.0 units on a scale
Standard Deviation 0.8
|
0.9 units on a scale
Standard Deviation 0.6
|
1.3 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 1hr, 6hr, 12hr, 24hr, and 48hr after surgeryPain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Questionnaire: Pain Scores on Movement
1 hr
|
2.7 units on a scale
Standard Deviation 1.2
|
2.4 units on a scale
Standard Deviation 1.1
|
4.3 units on a scale
Standard Deviation 0.8
|
|
Questionnaire: Pain Scores on Movement
6 hr
|
2.9 units on a scale
Standard Deviation 0.7
|
2.6 units on a scale
Standard Deviation 1.3
|
4.2 units on a scale
Standard Deviation 0.7
|
|
Questionnaire: Pain Scores on Movement
12 hr
|
3.3 units on a scale
Standard Deviation 0.5
|
3.7 units on a scale
Standard Deviation 0.9
|
4.0 units on a scale
Standard Deviation 0.8
|
|
Questionnaire: Pain Scores on Movement
24 hr
|
4.1 units on a scale
Standard Deviation 0.7
|
3.5 units on a scale
Standard Deviation 0.9
|
4.6 units on a scale
Standard Deviation 0.8
|
|
Questionnaire: Pain Scores on Movement
48 hr
|
4.2 units on a scale
Standard Deviation 0.8
|
3.5 units on a scale
Standard Deviation 0.8
|
4.5 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 weeksThe time of first flatus was measured after surgery.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Anesthesia Recovery: the Time of First Flatus
|
77.6 hour
Standard Deviation 10.4
|
78.4 hour
Standard Deviation 11.6
|
81.6 hour
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 weeksThe percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Anesthesia Recovery: Number of Participants With Prolonged Hospitalization
|
5 participants
|
5 participants
|
13 participants
|
SECONDARY outcome
Timeframe: up to 48h after surgeryThe state of sedation was evaluated after surgery during first postoperative 48 hours.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Side Effects: Number of Participants With Sedation
|
8 participants
|
5 participants
|
16 participants
|
SECONDARY outcome
Timeframe: up to 48h after surgeryThe state of nausea was evaluated after surgery during first postoperative 48 hours.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Side Effects: Number of Participants With Nausea
|
5 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: up to 48h after surgeryThe state of vomiting was evaluated after surgery during first postoperative 48 hours.
Outcome measures
| Measure |
Transversus Abdominis Plane Block
n=30 Participants
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 Participants
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 Participants
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Side Effects: Number of Participants With Vomiting
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
Transversus Abdominis Plane Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Anesthesia
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transversus Abdominis Plane Block
n=30 participants at risk
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
|
Epidural Anesthesia
n=28 participants at risk
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
|
Control
n=31 participants at risk
The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/30 • 1 month
|
7.1%
2/28 • Number of events 2 • 1 month
|
0.00%
0/31 • 1 month
|
Additional Information
Dr. Guoqing Zhao
China-Japan Unit Hospital of Jilin University
Phone: 0435-84995117
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place