Trial Outcomes & Findings for Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks (NCT NCT01898689)
NCT ID: NCT01898689
Last Updated: 2021-03-19
Results Overview
Electrocardiogram pads are placed on the lateral aspect of the plantar surface of the foot which is covered by the sciatic nerve distribution; and, the tolerance to cutaneous electrical current is obtained using a nerve stimulator. The current is increased from 0 mA until subjects detect the electrical current (up to a maximum of 80 mA), at which time the current is recorded and the nerve stimulator turned off.
COMPLETED
PHASE4
24 participants
Hour 6
2021-03-19
Participant Flow
Participant milestones
| Measure |
Right Side Ropivacaine 0.1%, Left Side Ropivacaine 0.4%
Ropivacaine 0.1% administered at 8 mL/h basal for 6 hours on the right side of the body while ropivacaine 0.4% administered at 2 mL/h basal for 6 hours on the left side of the body.
|
Right Side Ropivacaine 0.4%, Left Side Ropivacaine 0.1%
Ropivacaine 0.4% administered at 2 mL/h basal for 6 hours on the right side of the body while ropivacaine 0.1% administered at 8 mL/h basal for 6 hours on the left side of the body.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
14
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks
Baseline characteristics by cohort
| Measure |
Right Side: Ropivacaine 0.1%
n=10 Participants
Bilateral sciatic perineural catheters were inserted and ropivacaine infused as a basal infusion through both for 6 hours. The right side of the body received 0.1% at 8 mL/h and the left side of the body received 0.4% at 2 mL/h.
|
Right Side: Ropivacaine 0.4%
n=14 Participants
Bilateral sciatic perineural catheters were inserted and ropivacaine infused as a basal infusion through both for 6 hours. The right side of the body received 0.4% at 2 mL/h and the left side of the body received 0.1% at 8 mL/h.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Height
|
175 cm
STANDARD_DEVIATION 11 • n=93 Participants
|
175 cm
STANDARD_DEVIATION 11 • n=4 Participants
|
175 cm
STANDARD_DEVIATION 11 • n=27 Participants
|
|
Weight
|
87.0 kg
STANDARD_DEVIATION 15.3 • n=93 Participants
|
79.2 kg
STANDARD_DEVIATION 16.1 • n=4 Participants
|
81.0 kg
STANDARD_DEVIATION 17.0 • n=27 Participants
|
|
Body Mass Index
|
27.0 kg/m^2
STANDARD_DEVIATION 3.6 • n=93 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 5.0 • n=4 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 4.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: Hour 6Population: Since this was a split-body study, we included each individual who received the treatment. Since each of the 24 subjects received each of the treatments, the overall number of participants analyzed was 24 for each of the treatments. For this reason, the Total number of subjects appears to be '48', when in fact it was 48 treated sides.
Electrocardiogram pads are placed on the lateral aspect of the plantar surface of the foot which is covered by the sciatic nerve distribution; and, the tolerance to cutaneous electrical current is obtained using a nerve stimulator. The current is increased from 0 mA until subjects detect the electrical current (up to a maximum of 80 mA), at which time the current is recorded and the nerve stimulator turned off.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=24 Participants
Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.1% at 8 mL/h and the left side received 0.4% at 2 mL/h.
|
Ropivacaine 0.4%
n=24 Participants
Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.4% at 2 mL/h and the left side received 0.1% at 8 mL/h.
|
|---|---|---|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
|
27.0 mA (milliamperes)
Standard Deviation 20.2
|
26.9 mA (milliamperes)
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: baseline, Hours 1-14 (except 6 which was the primary outcome) and Hour 22Population: Since this was a split-body study, we included each individual who received the treatment. Since each of the 24 subjects received each of the treatments, the overall number of participants analyzed was 24 for each of the treatments. For this reason, the Total number of subjects appears to be '48', when in fact it was 48 treated sides.
Electrocardiogram pads are placed on the lateral aspect of the plantar surface of the foot which is covered by the sciatic nerve distribution; and, the tolerance to cutaneous electrical current is obtained using a nerve stimulator. The current is increased from 0 mA until subjects detect the electrical current (up to a maximum of 80 mA), at which time the current is recorded and the nerve stimulator turned off.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=24 Participants
Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.1% at 8 mL/h and the left side received 0.4% at 2 mL/h.
|
Ropivacaine 0.4%
n=24 Participants
Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.4% at 2 mL/h and the left side received 0.1% at 8 mL/h.
|
|---|---|---|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 11
|
23.5 mA (milliamperes)
Standard Error 2.5
|
24.3 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 12
|
25 mA (milliamperes)
Standard Error 2.5
|
22 mA (milliamperes)
Standard Error 2
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 13
|
19.5 mA (milliamperes)
Standard Error 1
|
21.2 mA (milliamperes)
Standard Error 1
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 14
|
23.5 mA (milliamperes)
Standard Error 2.5
|
21 mA (milliamperes)
Standard Error 2
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 22
|
17 mA (milliamperes)
Standard Error 1
|
17 mA (milliamperes)
Standard Error 1
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Baseline
|
23 mA (milliamperes)
Standard Error 2.5
|
22.5 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 1
|
19 mA (milliamperes)
Standard Error 1.5
|
20 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 2
|
18 mA (milliamperes)
Standard Error 1.2
|
19 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 3
|
20 mA (milliamperes)
Standard Error 2.5
|
20.4 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 4
|
25 mA (milliamperes)
Standard Error 3
|
21 mA (milliamperes)
Standard Error 2
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 5
|
25 mA (milliamperes)
Standard Error 2.5
|
24.5 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 7
|
27 mA (milliamperes)
Standard Error 2.5
|
26.5 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 8
|
27 mA (milliamperes)
Standard Error 2.5
|
27.5 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 9
|
23 mA (milliamperes)
Standard Error 2.5
|
23.5 mA (milliamperes)
Standard Error 2.5
|
|
Maximum Tolerance to Transcutaneous Electrical Stimulation
Hour 10
|
25 mA (milliamperes)
Standard Error 2.5
|
24.5 mA (milliamperes)
Standard Error 2.5
|
SECONDARY outcome
Timeframe: baseline, Hours 1-14 and Hour 22Population: Since this was a split-body study, we included each individual who received the treatment. Since each of the 24 subjects received each of the treatments, the overall number of participants analyzed was 24 for each of the treatments. For this reason, the Total number of subjects appears to be '48', when in fact it was 48 treated sides.
Muscle strength was evaluated with an isometric force electromechanical dynamometer (MicroFET2, Lafayette Instrument Company, Lafayette, IN) to measure the force produced during a MVIC during plantar flexion. The dynamometer was placed against the bed's foot board (immobile) and the subjects asked to take 2 seconds to come to maximum effort plantar flexing, maintaining this effort for 5 seconds, and then relaxing. The measurements immediately prior to perineural ropivacaine administration were designated as baseline measurements, and all subsequent measurements expressed as a percentage of the pre-infusion baseline.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=24 Participants
Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.1% at 8 mL/h and the left side received 0.4% at 2 mL/h.
|
Ropivacaine 0.4%
n=24 Participants
Bilateral sciatic perineural catheters are inserted and ropivacaine is infused as a basal infusion for 6 hours. The right side received 0.4% at 2 mL/h and the left side received 0.1% at 8 mL/h.
|
|---|---|---|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Baseline
|
100 percentage change from baseline MVIC
Standard Error 0
|
100 percentage change from baseline MVIC
Standard Error 0
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 1
|
90 percentage change from baseline MVIC
Standard Error 1.2
|
98 percentage change from baseline MVIC
Standard Error 1.5
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 2
|
8.1 percentage change from baseline MVIC
Standard Error 1.2
|
8.1 percentage change from baseline MVIC
Standard Error 1.2
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 3
|
81.5 percentage change from baseline MVIC
Standard Error 1.5
|
81.0 percentage change from baseline MVIC
Standard Error 1.5
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 4
|
71.0 percentage change from baseline MVIC
Standard Error 1.0
|
71.5 percentage change from baseline MVIC
Standard Error 1.0
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 5
|
66 percentage change from baseline MVIC
Standard Error 4.9
|
57 percentage change from baseline MVIC
Standard Error 1
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 6
|
57 percentage change from baseline MVIC
Standard Error 1.4
|
56 percentage change from baseline MVIC
Standard Error 1.4
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 7
|
58 percentage change from baseline MVIC
Standard Error 1
|
57 percentage change from baseline MVIC
Standard Error 1
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 8
|
61 percentage change from baseline MVIC
Standard Error 2.5
|
63 percentage change from baseline MVIC
Standard Error 2.5
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 9
|
67 percentage change from baseline MVIC
Standard Error 2.1
|
68 percentage change from baseline MVIC
Standard Error 2
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 10
|
68 percentage change from baseline MVIC
Standard Error 2
|
66 percentage change from baseline MVIC
Standard Error 2
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 11
|
70 percentage change from baseline MVIC
Standard Error 1.0
|
67 percentage change from baseline MVIC
Standard Error 1
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 12
|
72 percentage change from baseline MVIC
Standard Error 2.5
|
78.5 percentage change from baseline MVIC
Standard Error 2.5
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 13
|
80 percentage change from baseline MVIC
Standard Error 2.5
|
70 percentage change from baseline MVIC
Standard Error 2.5
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 14
|
78 percentage change from baseline MVIC
Standard Error 3
|
78 percentage change from baseline MVIC
Standard Error 3
|
|
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
Hour 22
|
96 percentage change from baseline MVIC
Standard Error 0.8
|
97 percentage change from baseline MVIC
Standard Error 1.1
|
Adverse Events
Ropivacaine 0.1%
Ropivacaine 0.4%
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