Trial Outcomes & Findings for The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance (NCT NCT02139982)
NCT ID: NCT02139982
Last Updated: 2014-08-01
Results Overview
These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
110 participants
Primary outcome timeframe
baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)
Results posted on
2014-08-01
Participant Flow
Participant milestones
| Measure |
Group MC(Phase 1)
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group A(Phase 2)
30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine
|
Group B(Phase 2)
30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine
|
Group C(Phase 2)
30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine
|
Group D(Phase 2)
30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine
|
Group E(Phase 2)
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
13
|
13
|
13
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
8
|
7
|
8
|
7
|
13
|
13
|
13
|
13
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group MC(Phase 1)
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group A(Phase 2)
30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine
|
Group B(Phase 2)
30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine
|
Group C(Phase 2)
30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine
|
Group D(Phase 2)
30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine
|
Group E(Phase 2)
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance
Baseline characteristics by cohort
| Measure |
Group MC(Phase 1)
n=8 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=8 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=8 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=8 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group A(Phase 2)
n=13 Participants
30ml ropivacaine 0.125%
ropivacaine: Different concentration of ropivacaine
|
Group B(Phase 2)
n=13 Participants
30ml ropivacaine 0.2%
ropivacaine: Different concentration of ropivacaine
|
Group C(Phase 2)
n=13 Participants
30ml ropivacaine 0.25%
ropivacaine: Different concentration of ropivacaine
|
Group D(Phase 2)
n=13 Participants
30ml ropivacaine 0.375%
ropivacaine: Different concentration of ropivacaine
|
Group E(Phase 2)
n=13 Participants
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
n=13 Participants
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 13 • n=5 Participants
|
31 years
STANDARD_DEVIATION 7 • n=7 Participants
|
42 years
STANDARD_DEVIATION 19 • n=5 Participants
|
38 years
STANDARD_DEVIATION 17 • n=4 Participants
|
31 years
STANDARD_DEVIATION 10 • n=21 Participants
|
36 years
STANDARD_DEVIATION 14 • n=8 Participants
|
41 years
STANDARD_DEVIATION 13 • n=8 Participants
|
34 years
STANDARD_DEVIATION 12 • n=24 Participants
|
42 years
STANDARD_DEVIATION 15 • n=42 Participants
|
46 years
STANDARD_DEVIATION 18 • n=42 Participants
|
39 years
STANDARD_DEVIATION 15 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
|
Region of Enrollment
China
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
13 participants
n=21 Participants
|
13 participants
n=8 Participants
|
13 participants
n=8 Participants
|
13 participants
n=24 Participants
|
13 participants
n=42 Participants
|
13 participants
n=42 Participants
|
110 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.
Outcome measures
| Measure |
Group MC(Phase 1)
n=8 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=7 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=8 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=7 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group E(Phase 2)
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
EDV of radial artery T1
|
3.6 cm/s
Standard Deviation 4.1
|
5.7 cm/s
Standard Deviation 3.3
|
9.3 cm/s
Standard Deviation 5.1
|
16.1 cm/s
Standard Deviation 5.3
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
EDV of radial artery T2
|
19.4 cm/s
Standard Deviation 3.7
|
20.4 cm/s
Standard Deviation 6.1
|
21.1 cm/s
Standard Deviation 8.0
|
18.0 cm/s
Standard Deviation 4.1
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
TAMAX of radial artery T0
|
10.2 cm/s
Standard Deviation 6.6
|
11.4 cm/s
Standard Deviation 4.2
|
13.1 cm/s
Standard Deviation 4.8
|
11.5 cm/s
Standard Deviation 7.0
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
PSV of radial artery T0
|
40.9 cm/s
Standard Deviation 12.2
|
39.6 cm/s
Standard Deviation 7.6
|
47.6 cm/s
Standard Deviation 18.6
|
42.6 cm/s
Standard Deviation 10.9
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
PSV of radial artery T1
|
40.7 cm/s
Standard Deviation 13.1
|
40.9 cm/s
Standard Deviation 9.4
|
50.5 cm/s
Standard Deviation 21.5
|
52.4 cm/s
Standard Deviation 9.8
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
PSV of radial artery T2
|
58.0 cm/s
Standard Deviation 7.2
|
60.1 cm/s
Standard Deviation 16.2
|
69.6 cm/s
Standard Deviation 13.6
|
58.5 cm/s
Standard Deviation 6.6
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
EDV of radial artery T0
|
3.4 cm/s
Standard Deviation 4.3
|
5.8 cm/s
Standard Deviation 3.3
|
6.0 cm/s
Standard Deviation 2.1
|
5.5 cm/s
Standard Deviation 5.3
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
TAMAX of radial artery T1
|
10.4 cm/s
Standard Deviation 6.2
|
11.2 cm/s
Standard Deviation 4.6
|
18.4 cm/s
Standard Deviation 7.8
|
24.8 cm/s
Standard Deviation 9.4
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
TAMAX of radial artery T2
|
32.0 cm/s
Standard Deviation 7.1
|
31.0 cm/s
Standard Deviation 9.2
|
33.3 cm/s
Standard Deviation 9.7
|
29.7 cm/s
Standard Deviation 5.5
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
PSV of ulnar artery T0
|
42.5 cm/s
Standard Deviation 12.9
|
45.8 cm/s
Standard Deviation 12.5
|
51.1 cm/s
Standard Deviation 14.6
|
43.9 cm/s
Standard Deviation 13.5
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
PSV of ulnar artery T1
|
40.2 cm/s
Standard Deviation 11.6
|
60.5 cm/s
Standard Deviation 13.2
|
53.9 cm/s
Standard Deviation 15.8
|
45.1 cm/s
Standard Deviation 11.6
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
PSV of ulnar artery T2
|
56.9 cm/s
Standard Deviation 9.8
|
68.7 cm/s
Standard Deviation 17.4
|
68.4 cm/s
Standard Deviation 12.2
|
62.8 cm/s
Standard Deviation 11.1
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
EDV of ulnar artery T0
|
5.9 cm/s
Standard Deviation 3.3
|
7.9 cm/s
Standard Deviation 5.0
|
6.0 cm/s
Standard Deviation 2.6
|
5.3 cm/s
Standard Deviation 4.5
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
EDV of ulnar artery T1
|
5.1 cm/s
Standard Deviation 2.9
|
21.6 cm/s
Standard Deviation 9.3
|
6.2 cm/s
Standard Deviation 3.0
|
7.4 cm/s
Standard Deviation 6.9
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
EDV of ulnar artery T2
|
19.6 cm/s
Standard Deviation 7.9
|
26.9 cm/s
Standard Deviation 9.7
|
18.8 cm/s
Standard Deviation 7.4
|
20.2 cm/s
Standard Deviation 9.5
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
TAMAX of ulnar artery T0
|
11.2 cm/s
Standard Deviation 6.0
|
14.9 cm/s
Standard Deviation 7.3
|
14.0 cm/s
Standard Deviation 4.8
|
11.1 cm/s
Standard Deviation 6.5
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
TAMAX of ulnar artery T1
|
10.9 cm/s
Standard Deviation 4.8
|
29.9 cm/s
Standard Deviation 12.1
|
14.0 cm/s
Standard Deviation 5.2
|
11.9 cm/s
Standard Deviation 6.9
|
—
|
—
|
|
Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
TAMAX of ulnar artery T2
|
27.8 cm/s
Standard Deviation 8.0
|
36.8 cm/s
Standard Deviation 14.2
|
30.5 cm/s
Standard Deviation 9.0
|
29.0 cm/s
Standard Deviation 9.8
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline, 30 min after brachial plexus blockThese parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX), resistance index (RI), and pulsatility index (PI),The cross-sectional area of the artery imaging.Blood flow (BF) = TAMAX× CSA×60s. Relative ratio of hemodymanic parameter=30 min after brachial plexus block divide by baseline
Outcome measures
| Measure |
Group MC(Phase 1)
n=13 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=13 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=13 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=13 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group E(Phase 2)
n=13 Participants
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
n=13 Participants
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|
|
Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)
relative ratio of PSV
|
1.031371 ratio
Interval 0.964707 to 1.140595
|
1.15 ratio
Interval 1.02 to 1.24
|
1.19 ratio
Interval 1.05 to 1.24
|
1.19 ratio
Interval 1.13 to 1.29
|
1.29 ratio
Interval 1.14 to 1.49
|
1.43 ratio
Interval 1.3 to 1.47
|
|
Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)
Relative ratio of TAMAX
|
1.21 ratio
Interval 1.13 to 1.49
|
1.56 ratio
Interval 1.5 to 1.84
|
1.84 ratio
Interval 1.67 to 1.99
|
2.09 ratio
Interval 1.9 to 2.28
|
2.34 ratio
Interval 2.3 to 2.57
|
2.57 ratio
Interval 2.36 to 2.93
|
|
Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)
Relative ratio of BF
|
1.40 ratio
Interval 1.32 to 1.58
|
1.87 ratio
Interval 1.69 to 2.1
|
2.10 ratio
Interval 1.9 to 2.36
|
2.54 ratio
Interval 2.29 to 2.81
|
3.18 ratio
Interval 3.0 to 3.35
|
3.53 ratio
Interval 3.28 to 3.67
|
|
Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)
Relative ratio of PI
|
0.75 ratio
Interval 0.68 to 0.8
|
0.61 ratio
Interval 0.56 to 0.72
|
0.53 ratio
Interval 0.45 to 0.57
|
0.47 ratio
Interval 0.44 to 0.57
|
0.44 ratio
Interval 0.36 to 0.5
|
0.43 ratio
Interval 0.37 to 0.49
|
|
Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)
Relative ratio of RI
|
0.91 ratio
Interval 0.9 to 0.93
|
0.87 ratio
Interval 0.87 to 0.92
|
0.85 ratio
Interval 0.79 to 0.87
|
0.84 ratio
Interval 0.8 to 0.86
|
0.81 ratio
Interval 0.77 to 0.86
|
0.82 ratio
Interval 0.76 to 0.89
|
PRIMARY outcome
Timeframe: baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)The cross-sectional area(CSA, cm2) of Radial/ulnar Artery was assessed with B-mode imaging. Probe was kept perpendicular to the long axis of the artery to obtain the largest oval arterial section. The image at end diastole was chosen and measured with the cine loop.
Outcome measures
| Measure |
Group MC(Phase 1)
n=8 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=7 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=8 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=7 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group E(Phase 2)
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|
|
Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
CAS of ulnar artery T0
|
0.039 cm^2
Standard Deviation 0.019
|
0.039 cm^2
Standard Deviation 0.011
|
0.043 cm^2
Standard Deviation 0.014
|
0.050 cm^2
Standard Deviation 0.013
|
—
|
—
|
|
Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
CSA of radial artery T0
|
0.051 cm^2
Standard Deviation 0.008
|
0.051 cm^2
Standard Deviation 0.009
|
0.040 cm^2
Standard Deviation 0.015
|
0.051 cm^2
Standard Deviation 0.012
|
—
|
—
|
|
Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
CSA of radial artery T1
|
0.053 cm^2
Standard Deviation 0.005
|
0.053 cm^2
Standard Deviation 0.005
|
0.044 cm^2
Standard Deviation 0.018
|
0.069 cm^2
Standard Deviation 0.013
|
—
|
—
|
|
Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
CSA of radial artery T2
|
0.073 cm^2
Standard Deviation 0.014
|
0.074 cm^2
Standard Deviation 0.014
|
0.061 cm^2
Standard Deviation 0.014
|
0.073 cm^2
Standard Deviation 0.014
|
—
|
—
|
|
Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
CAS of ulnar artery T1
|
0.039 cm^2
Standard Deviation 0.018
|
0.059 cm^2
Standard Deviation 0.016
|
0.044 cm^2
Standard Deviation 0.011
|
0.056 cm^2
Standard Deviation 0.014
|
—
|
—
|
|
Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)
CAS of ulnar artery T2
|
0.061 cm^2
Standard Deviation 0.022
|
0.061 cm^2
Standard Deviation 0.015
|
0.068 cm^2
Standard Deviation 0.013
|
0.069 cm^2
Standard Deviation 0.018
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, 30 min after specific nerve block, 30 min after brachial plexus blockSkin temperature(Ts) was measured at four different points within the cutaneous innervation areas of the musculocutaneous(lateral skin of forearm), ulnar(hypothenar region), radial (thumb-index web) and median(thenar) Specific points were located with skin marker to provide consistency of measurement.
Outcome measures
| Measure |
Group MC(Phase 1)
n=8 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=7 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=8 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=7 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group E(Phase 2)
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts MC t0
|
30.0 ℃
Standard Deviation 0.8
|
29.8 ℃
Standard Deviation 0.8
|
30.2 ℃
Standard Deviation 0.9
|
30.0 ℃
Standard Deviation 0.7
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts MC t1
|
29.9 ℃
Standard Deviation 0.8
|
30.0 ℃
Standard Deviation 0.9
|
30.1 ℃
Standard Deviation 1.0
|
30.4 ℃
Standard Deviation 0.6
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts MC t2
|
31.3 ℃
Standard Deviation 0.6
|
31.1 ℃
Standard Deviation 0.9
|
33.4 ℃
Standard Deviation 1.0
|
33.7 ℃
Standard Deviation 0.9
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts UL t0
|
29.1 ℃
Standard Deviation 1.3
|
30.1 ℃
Standard Deviation 0.8
|
29.5 ℃
Standard Deviation 1.1
|
29.7 ℃
Standard Deviation 0.9
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts UL t1
|
29.0 ℃
Standard Deviation 1.2
|
32.4 ℃
Standard Deviation 0.6
|
29.6 ℃
Standard Deviation 1.1
|
29.8 ℃
Standard Deviation 1.0
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts UL t2
|
31.9 ℃
Standard Deviation 1.3
|
32.6 ℃
Standard Deviation 0.6
|
32.6 ℃
Standard Deviation 1.3
|
32.9 ℃
Standard Deviation 0.6
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts RA t0
|
30.5 ℃
Standard Deviation 1.3
|
30.5 ℃
Standard Deviation 1.6
|
29.5 ℃
Standard Deviation 1.5
|
30.1 ℃
Standard Deviation 0.7
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts RA t1
|
30.5 ℃
Standard Deviation 1.3
|
30.5 ℃
Standard Deviation 1.3
|
29.7 ℃
Standard Deviation 1.6
|
32.7 ℃
Standard Deviation 1.0
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts RA t2
|
32.6 ℃
Standard Deviation 1.0
|
33.2 ℃
Standard Deviation 1.1
|
32.2 ℃
Standard Deviation 1.1
|
33.9 ℃
Standard Deviation 1.0
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts ME t0
|
28.9 ℃
Standard Deviation 1.7
|
30.0 ℃
Standard Deviation 1.3
|
29.5 ℃
Standard Deviation 1.6
|
29.8 ℃
Standard Deviation 0.9
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts ME t1
|
29.0 ℃
Standard Deviation 1.7
|
30.1 ℃
Standard Deviation 1.3
|
29.5 ℃
Standard Deviation 1.4
|
33.3 ℃
Standard Deviation 0.8
|
—
|
—
|
|
Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)
Ts ME t2
|
32.4 ℃
Standard Deviation 1.4
|
32.7 ℃
Standard Deviation 1.2
|
32.0 ℃
Standard Deviation 1.3
|
33.7 ℃
Standard Deviation 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 min after brachial plexus blockSuccess of Brachial Plexus Block(BPB) was defined as the absence of sensation to in all innervation areas of above four nerves (musculocutaneous, ulnar, radial, and median nerves) 30min. after the BPB and no pain during the surgery.
Outcome measures
| Measure |
Group MC(Phase 1)
n=13 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=13 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=13 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=13 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group E(Phase 2)
n=13 Participants
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
n=13 Participants
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|
|
Success of Brachial Plexus Block ( Phase 2)
|
1 participants
|
9 participants
|
11 participants
|
12 participants
|
13 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline,30 min after brachial plexus blockSkin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline
Outcome measures
| Measure |
Group MC(Phase 1)
n=13 Participants
specific nerve block:musculocutaneous nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group UL( Phase 1)
n=13 Participants
specific nerve block:ulnar nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group RA (Phase 1)
n=13 Participants
specific nerve block:radial nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group ME (Phase 1)
n=13 Participants
specific nerve block:median nerve block
specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
|
Group E(Phase 2)
n=13 Participants
30ml ropivacaine 0.5%
ropivacaine: Different concentration of ropivacaine
|
Group F(Phase 2)
n=13 Participants
30ml ropivacaine 0.75%
ropivacaine: Different concentration of ropivacaine
|
|---|---|---|---|---|---|---|
|
Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)
|
1.18 ℃
Standard Deviation 0.68
|
1.91 ℃
Standard Deviation 0.81
|
2.27 ℃
Standard Deviation 0.84
|
2.32 ℃
Standard Deviation 0.92
|
2.44 ℃
Standard Deviation 1.06
|
2.43 ℃
Standard Deviation 1.10
|
Adverse Events
Group MC(Phase 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group UL( Phase 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group RA (Phase 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group ME (Phase 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group A(Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B(Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C(Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D(Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group E(Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group F(Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ting Li
The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Phone: 008613587876896
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place