Trial Outcomes & Findings for Continuous Adductor Canal Nerve Blocks: Relative Effects of a Basal Infusion v. Hourly Bolus Doses (NCT NCT02219438)
NCT ID: NCT02219438
Last Updated: 2021-03-19
Results Overview
Evaluated in the seated position using transcutaneous electrical stimulation (TES) in the same manner as described throughout the anesthesia literature (this is a "gold standard" for regional anesthesia studies). EKG pads will be positioned over the proximal patella and quadriceps tendon 1 cm medial of midline and attached to a nerve stimulator. The current will be increased from 0 mA until the subject reports slight discomfort (or, up to a maximum of 80 mA), at which time the current is recorded as the TES value and the nerve stimulator turned off.
COMPLETED
PHASE4
24 participants
After 8 h of infusion
2021-03-19
Participant Flow
This was a split-body study design, so while there were 24 human subjects involved; each had two treatments: one bolus and one basal. Therefore there were 24 sides receiving the "bolus" treatment and 24 sides receiving the "basal" treatment
Participant milestones
| Measure |
Right Side Bolus, Left Side Basal
The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
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Right Side Basal, Left Side Bolus
The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
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|---|---|---|
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Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Right Side BOLUS and Left Side BASAL
n=13 Participants
The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
|
Right Side BASAL and Left Side BOLUS
n=11 Participants
The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
11 Participants
n=11 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=13 Participants
|
7 Participants
n=11 Participants
|
17 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=13 Participants
|
4 Participants
n=11 Participants
|
7 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
11 participants
n=11 Participants
|
24 participants
n=24 Participants
|
|
Height
|
173 cm
STANDARD_DEVIATION 8 • n=13 Participants
|
175 cm
STANDARD_DEVIATION 10 • n=11 Participants
|
174 cm
STANDARD_DEVIATION 9 • n=24 Participants
|
|
Weight
|
74 kg
STANDARD_DEVIATION 12 • n=13 Participants
|
79 kg
STANDARD_DEVIATION 14 • n=11 Participants
|
76 kg
STANDARD_DEVIATION 13 • n=24 Participants
|
|
Dominant Leg was the RIGHT leg
|
13 participants
n=13 Participants
|
11 participants
n=11 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: After 8 h of infusionEvaluated in the seated position using transcutaneous electrical stimulation (TES) in the same manner as described throughout the anesthesia literature (this is a "gold standard" for regional anesthesia studies). EKG pads will be positioned over the proximal patella and quadriceps tendon 1 cm medial of midline and attached to a nerve stimulator. The current will be increased from 0 mA until the subject reports slight discomfort (or, up to a maximum of 80 mA), at which time the current is recorded as the TES value and the nerve stimulator turned off.
Outcome measures
| Measure |
BOLUS
n=24 Participants
The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
|
BASAL
n=24 Participants
The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
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|---|---|---|
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Tolerance to Cutaneous Electrical Current
|
26.6 mA
Standard Deviation 12.1
|
27.1 mA
Standard Deviation 14.5
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SECONDARY outcome
Timeframe: baseline through Hour 14 (except Hour 8 which is the primary outcome) and then again at Hour 22Evaluated in the seated position using transcutaneous electrical stimulation (TES) in the same manner as described throughout the anesthesia literature (this is a "gold standard" for regional anesthesia studies). EKG pads will be positioned over the proximal patella and quadriceps tendon 1 cm medial of midline and attached to a nerve stimulator. The current will be increased from 0 mA until the subject reports slight discomfort (or, up to a maximum of 80 mA), at which time the current is recorded as the TES value and the nerve stimulator turned off.
Outcome measures
| Measure |
BOLUS
n=24 Participants
The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
|
BASAL
n=24 Participants
The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
|
|---|---|---|
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Tolerance to Transcutaneous Electrical Current
Baseline
|
26.7 mA (milliamperes)
Standard Deviation 7.6
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26.6 mA (milliamperes)
Standard Deviation 7.2
|
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Tolerance to Transcutaneous Electrical Current
Hour 1
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26.8 mA (milliamperes)
Standard Deviation 8.8
|
24.7 mA (milliamperes)
Standard Deviation 7.8
|
|
Tolerance to Transcutaneous Electrical Current
Hour 2
|
27.9 mA (milliamperes)
Standard Deviation 9.0
|
27.4 mA (milliamperes)
Standard Deviation 8.2
|
|
Tolerance to Transcutaneous Electrical Current
Hour 3
|
27.8 mA (milliamperes)
Standard Deviation 9.6
|
29.7 mA (milliamperes)
Standard Deviation 13.3
|
|
Tolerance to Transcutaneous Electrical Current
Hour 4
|
30.0 mA (milliamperes)
Standard Deviation 14.0
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29.7 mA (milliamperes)
Standard Deviation 14.6
|
|
Tolerance to Transcutaneous Electrical Current
Hour 5
|
29.5 mA (milliamperes)
Standard Deviation 13.7
|
30.1 mA (milliamperes)
Standard Deviation 14.5
|
|
Tolerance to Transcutaneous Electrical Current
Hour 6
|
29.0 mA (milliamperes)
Standard Deviation 14.0
|
29.0 mA (milliamperes)
Standard Deviation 14.8
|
|
Tolerance to Transcutaneous Electrical Current
Hour 7
|
26.8 mA (milliamperes)
Standard Deviation 12.1
|
25.9 mA (milliamperes)
Standard Deviation 11.3
|
|
Tolerance to Transcutaneous Electrical Current
Hour 9
|
22.7 mA (milliamperes)
Standard Deviation 8.8
|
24.3 mA (milliamperes)
Standard Deviation 10.6
|
|
Tolerance to Transcutaneous Electrical Current
Hour 10
|
22.6 mA (milliamperes)
Standard Deviation 8.6
|
24.9 mA (milliamperes)
Standard Deviation 10.5
|
|
Tolerance to Transcutaneous Electrical Current
Hour 11
|
21.1 mA (milliamperes)
Standard Deviation 8.4
|
25.0 mA (milliamperes)
Standard Deviation 12.1
|
|
Tolerance to Transcutaneous Electrical Current
Hour 12
|
21.3 mA (milliamperes)
Standard Deviation 7.8
|
24.6 mA (milliamperes)
Standard Deviation 12.7
|
|
Tolerance to Transcutaneous Electrical Current
Hour 13
|
21.2 mA (milliamperes)
Standard Deviation 7.4
|
23.2 mA (milliamperes)
Standard Deviation 9.4
|
|
Tolerance to Transcutaneous Electrical Current
Hour 14
|
21.1 mA (milliamperes)
Standard Deviation 7.9
|
22.3 mA (milliamperes)
Standard Deviation 8.8
|
|
Tolerance to Transcutaneous Electrical Current
Hour 22
|
24.1 mA (milliamperes)
Standard Deviation 8.8
|
24.5 mA (milliamperes)
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline and then every hour through Hour 14, as well as Hour 22Strength of the quadriceps muscle was assessed by measurement of maximum voluntary isometric contraction. In the sitting position, without using accessory muscle groups, subjects performed maximum forceful knee extension against an electromechanical dynamometer (MicroFET2, Lafayette Instrument Company, Lafeyette, IN). The subject sat at the side of the bed with their legs dangling. The device was placed against the anterior tibia just above the malleoli between the subject and a nonelastic 5 cm-wide fabric band that was affixed to the gurney to stabilize the dynamometer during flexing of the quadriceps femoris muscle. Subjects were instructed to come to maximum force of knee extension over 2 seconds, hold this force for 5 seconds, and then relax. The maximum force was recorded, and results are reported relative to the pre-infusion baseline measurement (i.e., percent of baseline).
Outcome measures
| Measure |
BOLUS
n=24 Participants
The right side received ropivacaine 0.2% administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses. Since it is a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) for 8 hours total.
|
BASAL
n=24 Participants
The right side received ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) for 8 hours total. Since it was a split body study, the left side of the body of these participants received ropivacaine 0.2% perineural administration as repeated 8 mL bolus doses starting at time point 0 and given hourly for 7 additional doses.
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|---|---|---|
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Maximum Voluntary Isometric Contraction of the Quadriceps
Baseline
|
188 percentage of baseline MVIC
Standard Deviation 65
|
188 percentage of baseline MVIC
Standard Deviation 78
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 1
|
84 percentage of baseline MVIC
Standard Deviation 27
|
88 percentage of baseline MVIC
Standard Deviation 36
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 2
|
89 percentage of baseline MVIC
Standard Deviation 21
|
87 percentage of baseline MVIC
Standard Deviation 30
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 3
|
95 percentage of baseline MVIC
Standard Deviation 25
|
93 percentage of baseline MVIC
Standard Deviation 32
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 4
|
92 percentage of baseline MVIC
Standard Deviation 34
|
87 percentage of baseline MVIC
Standard Deviation 31
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 5
|
95 percentage of baseline MVIC
Standard Deviation 38
|
90 percentage of baseline MVIC
Standard Deviation 29
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 6
|
88 percentage of baseline MVIC
Standard Deviation 34
|
93 percentage of baseline MVIC
Standard Deviation 91
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 7
|
85 percentage of baseline MVIC
Standard Deviation 35
|
92 percentage of baseline MVIC
Standard Deviation 29
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 8
|
88 percentage of baseline MVIC
Standard Deviation 31
|
94 percentage of baseline MVIC
Standard Deviation 32
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 9
|
86 percentage of baseline MVIC
Standard Deviation 30
|
87 percentage of baseline MVIC
Standard Deviation 30
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 10
|
89 percentage of baseline MVIC
Standard Deviation 36
|
90 percentage of baseline MVIC
Standard Deviation 32
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 11
|
89 percentage of baseline MVIC
Standard Deviation 36
|
87 percentage of baseline MVIC
Standard Deviation 30
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 12
|
87 percentage of baseline MVIC
Standard Deviation 35
|
84 percentage of baseline MVIC
Standard Deviation 29
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 13
|
84 percentage of baseline MVIC
Standard Deviation 32
|
89 percentage of baseline MVIC
Standard Deviation 31
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 14
|
85 percentage of baseline MVIC
Standard Deviation 30
|
88 percentage of baseline MVIC
Standard Deviation 29
|
|
Maximum Voluntary Isometric Contraction of the Quadriceps
Hour 22
|
114 percentage of baseline MVIC
Standard Deviation 35
|
119 percentage of baseline MVIC
Standard Deviation 39
|
Adverse Events
Bolus
Basal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place