Trial Outcomes & Findings for EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks (NCT NCT01349140)
NCT ID: NCT01349140
Last Updated: 2021-03-25
Results Overview
A dynamometer was used to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90°. The dynamometer was placed on the anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the ipsilateral quadriceps femoris, maintain this effort for 5 seconds, and then relax. The measurements immediately before study drug administration were designated baseline, and all subsequent are expressed as a percentage of the baseline.
COMPLETED
PHASE1
14 participants
Baseline until 99 hours
2021-03-25
Participant Flow
We enrolled 14 subjects, and therefore "Protocol Enrollment" is "14". However, each leg of each subject was treated separately with a different dose of liposomal bupivacaine (Exparel); and, therefore the number of units analyzed is 28.
Unit of analysis: Side (left or right)
Participant milestones
| Measure |
Nerve Block
EXPAREL: active liposome bupivacaine
|
|---|---|
|
Overall Study
STARTED
|
14 28
|
|
Overall Study
COMPLETED
|
14 28
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks
Baseline characteristics by cohort
| Measure |
Nerve Block
n=14 Participants
Exparel: liposome bupivacaine
|
|---|---|
|
Age, Continuous
|
35 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline until 99 hoursPopulation: Each of 14 subjects had a different dose of medication administered to each the left and right sides, and therefore there were 14 subjects, 28 units analyzed.
A dynamometer was used to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90°. The dynamometer was placed on the anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the ipsilateral quadriceps femoris, maintain this effort for 5 seconds, and then relax. The measurements immediately before study drug administration were designated baseline, and all subsequent are expressed as a percentage of the baseline.
Outcome measures
| Measure |
Nerve Block
n=28 side of the body (left or right)
Exparel: liposome bupivacaine
|
|---|---|
|
Quadriceps Femoris Muscle Strength
Leg #1: Dose 0 mg nondominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #2: Dose 0 mg nondominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #3: Dose 0 mg nondominant
|
9 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #4: Dose 0 mg dominant
|
13 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #5: Dose 1 mg dominant
|
12 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #6: Dose 2 mg Nondominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #7: Dose 3 mg Dominant
|
8 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #8: Dose 4 mg dominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #9: Dose 7 mg nondominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #10: Dose 10 mg nondominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #11: Dose 15 mg dominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #12: Dose 20 mg dominant
|
NA percentage of baseline measurement
Unavailable due to observation error by research nurse.
|
|
Quadriceps Femoris Muscle Strength
Leg #13: Dose 25 mg dominant
|
31 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #14: Dose 30 mg dominant
|
52 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #15: Dose 35 mg nondominant
|
27 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #16: Dose 40 mg nondominant
|
74 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #17: Dose 40 mg nondominant
|
49 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #18: Dose 50 mg nondominant
|
13 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #19: Dose 60 mg dominant
|
52 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #20: Dose 60 mg dominant
|
28 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #21: Dose 60 mg dominant
|
39 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #22: Dose 60 mg nondominant
|
60 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #23: Dose 70 mg dominant
|
40 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #24: Dose 80 mg dominant
|
9 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #25: Dose 80 mg dominant
|
81 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #26: Dose 80 mg nondominant
|
41 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #27: Dose 80 mg nondominant
|
11 percentage of baseline measurement
|
|
Quadriceps Femoris Muscle Strength
Leg #28: Dose 80 mg nondominant
|
37 percentage of baseline measurement
|
SECONDARY outcome
Timeframe: Baseline until 99 hoursPopulation: Each of 14 subjects had a different dose of medication administered to each the left and right sides, and therefore there were 14 subjects, 28 units analyzed.
We evaluated tolerance of transcutaneous electrical stimulation with the same quantitative procedure as described previously. Electrocardiogram pads were placed 2 cm medial to the distal quadriceps tendon and attached to a nerve stimulator (EZstimII, Model ES400; Life-Tech, Stafford, TX). The current was increased from 0 mA until subjects described mild discomfort, at which time the current was recorded as the tolerated level and the nerve stimulator turned off. All sensory measurements are expressed as a percentage of each patient's pre-infusion baseline.
Outcome measures
| Measure |
Nerve Block
n=28 side of the body (left or right)
Exparel: liposome bupivacaine
|
|---|---|
|
Sensory Effect
Leg #7: Dose 3 mg Dominant
|
NA percentage of baseline measurement
Subject never exhibited a sensory block \>100% of baseline
|
|
Sensory Effect
Leg #1: Dose 0 mg nondominant
|
127 percentage of baseline measurement
|
|
Sensory Effect
Leg #2: Dose 0 mg nondominant
|
275 percentage of baseline measurement
|
|
Sensory Effect
Leg #3: Dose 0 mg nondominant
|
486 percentage of baseline measurement
|
|
Sensory Effect
Leg #4: Dose 0 mg dominant
|
209 percentage of baseline measurement
|
|
Sensory Effect
Leg #5: Dose 1 mg dominant
|
400 percentage of baseline measurement
|
|
Sensory Effect
Leg #6: Dose 2 mg Nondominant
|
NA percentage of baseline measurement
Subject never exhibited a sensory block \>100% of baseline
|
|
Sensory Effect
Leg #8: Dose 4 mg dominant
|
125 percentage of baseline measurement
|
|
Sensory Effect
Leg #9: Dose 7 mg nondominant
|
NA percentage of baseline measurement
Subject never exhibited a sensory block \>100% of baseline
|
|
Sensory Effect
Leg #10: Dose 10 mg nondominant
|
127 percentage of baseline measurement
|
|
Sensory Effect
Leg #11: Dose 15 mg dominant
|
300 percentage of baseline measurement
|
|
Sensory Effect
Leg #12: Dose 20 mg dominant
|
156 percentage of baseline measurement
|
|
Sensory Effect
Leg #13: Dose 25 mg dominant
|
107 percentage of baseline measurement
|
|
Sensory Effect
Leg #14: Dose 30 mg dominant
|
NA percentage of baseline measurement
Subject never exhibited a sensory block \>100% of baseline
|
|
Sensory Effect
Leg #15: Dose 35 mg nondominant
|
225 percentage of baseline measurement
|
|
Sensory Effect
Leg #16: Dose 40 mg nondominant
|
NA percentage of baseline measurement
Subject never exhibited a sensory block \>100% of baseline
|
|
Sensory Effect
Leg #17: Dose 40 mg nondominant
|
109 percentage of baseline measurement
|
|
Sensory Effect
Leg #18: Dose 50 mg nondominant
|
300 percentage of baseline measurement
|
|
Sensory Effect
Leg #19: Dose 60 mg dominant
|
150 percentage of baseline measurement
|
|
Sensory Effect
Leg #20: Dose 60 mg dominant
|
190 percentage of baseline measurement
|
|
Sensory Effect
Leg #21: Dose 60 mg dominant
|
157 percentage of baseline measurement
|
|
Sensory Effect
Leg #22: Dose 60 mg nondominant
|
200 percentage of baseline measurement
|
|
Sensory Effect
Leg #23: Dose 70 mg dominant
|
229 percentage of baseline measurement
|
|
Sensory Effect
Leg #24: Dose 80 mg dominant
|
363 percentage of baseline measurement
|
|
Sensory Effect
Leg #25: Dose 80 mg dominant
|
325 percentage of baseline measurement
|
|
Sensory Effect
Leg #26: Dose 80 mg nondominant
|
150 percentage of baseline measurement
|
|
Sensory Effect
Leg #27: Dose 80 mg nondominant
|
200 percentage of baseline measurement
|
|
Sensory Effect
Leg #28: Dose 80 mg nondominant
|
138 percentage of baseline measurement
|
Adverse Events
Nerve Block
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nerve Block
n=14 participants at risk
Exparel: liposome bupivacaine
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place