Trial Outcomes & Findings for Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty (NCT NCT03182933)
NCT ID: NCT03182933
Last Updated: 2019-06-25
Results Overview
Time to comfortably walk 10 meters as deemed safe by physical therapy
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
24 hours
Results posted on
2019-06-25
Participant Flow
Study aimed to obtain 70 patients to account for dropout, however was sufficiently powered if 60 patients enrolled. Study was terminated after 64th patient due to surgeon preferences.
Participant milestones
| Measure |
Liposomal Bupivacaine Group
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 Participants
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 9.5 • n=31 Participants
|
64.8 years
STANDARD_DEVIATION 6.9 • n=32 Participants
|
65.8 years
STANDARD_DEVIATION 12.9 • n=63 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=31 Participants
|
21 Participants
n=32 Participants
|
46 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=31 Participants
|
11 Participants
n=32 Participants
|
17 Participants
n=63 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
32 participants
n=32 Participants
|
63 participants
n=63 Participants
|
PRIMARY outcome
Timeframe: 24 hoursTime to comfortably walk 10 meters as deemed safe by physical therapy
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 Participants
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
10 Meter Walk Test
|
17.1 seconds
Standard Deviation 8.9
|
13.4 seconds
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Day 0, Day 1, Day 2, Day 3Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 Participants
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
Pain Scores
Day 1
|
4.1 score on a scale
Standard Deviation 2.3
|
4.5 score on a scale
Standard Deviation 2.4
|
|
Pain Scores
Day 2
|
4.4 score on a scale
Standard Deviation 2.0
|
5.9 score on a scale
Standard Deviation 2.6
|
|
Pain Scores
Day 3
|
4.5 score on a scale
Standard Deviation 2.2
|
5 score on a scale
Standard Deviation 2.3
|
|
Pain Scores
Day 0
|
4.9 score on a scale
Standard Deviation 2.4
|
5.7 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 Participants
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
Opioid Consumption in Morphine Equivalents
Day 0 (OR)
|
2.3 Morphine equivalents
Standard Deviation 6.9
|
0.5 Morphine equivalents
Standard Deviation 2.7
|
|
Opioid Consumption in Morphine Equivalents
Day 0 (PACU)
|
7.1 Morphine equivalents
Standard Deviation 8.4
|
5.9 Morphine equivalents
Standard Deviation 11.4
|
|
Opioid Consumption in Morphine Equivalents
Day 1
|
51.2 Morphine equivalents
Standard Deviation 29.2
|
66.1 Morphine equivalents
Standard Deviation 36.0
|
|
Opioid Consumption in Morphine Equivalents
Day 2
|
39.5 Morphine equivalents
Standard Deviation 28.6
|
54.8 Morphine equivalents
Standard Deviation 37.9
|
|
Opioid Consumption in Morphine Equivalents
Day 3
|
25.8 Morphine equivalents
Standard Deviation 33.0
|
28.2 Morphine equivalents
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Day 0, Day 1, Day 2, Day 3Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 Participants
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
Number of Participants Who Experienced Nausea
Day 0 (PACU)
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Nausea
Day 1
|
12 Participants
|
11 Participants
|
|
Number of Participants Who Experienced Nausea
Day 2
|
3 Participants
|
6 Participants
|
|
Number of Participants Who Experienced Nausea
Day 3
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 hoursQuadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.
Outcome measures
| Measure |
Liposomal Bupivacaine Group
n=31 Participants
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 Participants
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
Quadriceps Strength
|
16.5 Pounds of Force
Standard Deviation 11
|
19.2 Pounds of Force
Standard Deviation 12.8
|
Adverse Events
Liposomal Bupivacaine Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard Bupivacaine Group
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 |
Liposomal Bupivacaine Group
n=31 participants at risk
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
Standard Bupivacaine Group
n=32 participants at risk
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Falls
|
3.2%
1/31 • Number of events 1 • Up to 72 hours
Any events that were deemed to be reportable events were discussed with the IRB
|
0.00%
0/32 • Up to 72 hours
Any events that were deemed to be reportable events were discussed with the IRB
|
Additional Information
Laura Zitur - research program manager
University of Wisconsin
Phone: 6082638118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place