Trial Outcomes & Findings for Exparel Use in Adductor Canal Block After Total Knee Arthroplasty (NCT NCT04910165)
NCT ID: NCT04910165
Last Updated: 2022-05-20
Results Overview
Inpatient post-operative stay after undergoing TKA procedure
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Through entire inpatient hospital stay (lasted from 1 day to 1 week)
Results posted on
2022-05-20
Participant Flow
Patients that presented to our outpatient Orthopaedic clinic and signed up to undergo a Total Knee Arthroplasty (TKA) were eligible for our study. No additional advertising was used.
Participant milestones
| Measure |
Exparel
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
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 |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
n=50 Participants
|
66.2 years
n=50 Participants
|
66.2 years
n=100 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=50 Participants
|
29 Participants
n=50 Participants
|
54 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=50 Participants
|
21 Participants
n=50 Participants
|
46 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
BMI
|
32.2 kg/m^2
n=50 Participants
|
32.3 kg/m^2
n=50 Participants
|
32.25 kg/m^2
n=100 Participants
|
|
American Society of Anesthesiology (ASA) Score
ASA 2
|
26 Participants
n=50 Participants
|
26 Participants
n=50 Participants
|
52 Participants
n=100 Participants
|
|
American Society of Anesthesiology (ASA) Score
ASA 3
|
24 Participants
n=50 Participants
|
24 Participants
n=50 Participants
|
48 Participants
n=100 Participants
|
|
Smoking
Yes
|
10 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
19 Participants
n=100 Participants
|
|
Smoking
No
|
40 Participants
n=50 Participants
|
41 Participants
n=50 Participants
|
81 Participants
n=100 Participants
|
|
Kellgren and Lawrence Osteoarthritis Grade
2
|
5 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
14 Participants
n=100 Participants
|
|
Kellgren and Lawrence Osteoarthritis Grade
3
|
29 Participants
n=50 Participants
|
24 Participants
n=50 Participants
|
53 Participants
n=100 Participants
|
|
Kellgren and Lawrence Osteoarthritis Grade
4
|
16 Participants
n=50 Participants
|
17 Participants
n=50 Participants
|
33 Participants
n=100 Participants
|
|
Previous Surgery
Yes
|
16 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
27 Participants
n=100 Participants
|
|
Previous Surgery
No
|
34 Participants
n=50 Participants
|
39 Participants
n=50 Participants
|
73 Participants
n=100 Participants
|
|
Previous TKA
Yes
|
10 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
19 Participants
n=100 Participants
|
|
Previous TKA
No
|
40 Participants
n=50 Participants
|
41 Participants
n=50 Participants
|
81 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Through entire inpatient hospital stay (lasted from 1 day to 1 week)Inpatient post-operative stay after undergoing TKA procedure
Outcome measures
| Measure |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Hospital Length of Stay
|
36.3 Hours
Standard Deviation 12.4
|
49.7 Hours
Standard Deviation 35.3
|
PRIMARY outcome
Timeframe: 1 weekOpioid usage during their inpatient post-operative hospital stay
Outcome measures
| Measure |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Inpatient Opioid Use
|
40.9 Milimorphine Equivalents/Day
Standard Deviation 20.7
|
47.3 Milimorphine Equivalents/Day
Standard Deviation 27.9
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Number of patients available in Post-operative day (POD) 2 lower secondary to earlier discharges. Number of patients available for analysis in in POD 7-42 time points secondary to their follow up). To account for this, both an "intention to treat" and a "per protocol" analysis were completed.
Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels.
Outcome measures
| Measure |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 0
|
1.8 units on a scale
Standard Deviation 2.7
|
-0.2 units on a scale
Standard Deviation 2.7
|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 1
|
1.0 units on a scale
Standard Deviation 2.7
|
-1.3 units on a scale
Standard Deviation 2.4
|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 2
|
2.3 units on a scale
Standard Deviation 2.6
|
-0.1 units on a scale
Standard Deviation 2.3
|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 7
|
1.8 units on a scale
Standard Deviation 3.5
|
0.2 units on a scale
Standard Deviation 2.9
|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 14
|
3.2 units on a scale
Standard Deviation 3.2
|
1.3 units on a scale
Standard Deviation 3.0
|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 28
|
3.9 units on a scale
Standard Deviation 2.6
|
2.2 units on a scale
Standard Deviation 2.9
|
|
Numeric Rating Scale (NRS) Pain Score Improvement
POD 42
|
5.2 units on a scale
Standard Deviation 2.7
|
3.0 units on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 6 weeksOpioid usage in the immediate post-operative period after hospital discharge
Outcome measures
| Measure |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Outpatient Opioid Use
|
33.4 Milimorphine Equivalents/Day
Standard Deviation 11.6
|
32.1 Milimorphine Equivalents/Day
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Number of patients available for analysis in in POD 7-42 time points decreased secondary to their follow up. To account for this, both an "intention to treat" and a "per protocol" analysis were completed.
Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels.
Outcome measures
| Measure |
Exparel
n=44 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=44 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
WOMAC Score
POD 7 Stiffness Subscore
|
1.5 units on a scale
Standard Deviation 2.7
|
0.2 units on a scale
Standard Deviation 2.8
|
|
WOMAC Score
POD 7 Physical Function Subscore
|
14.8 units on a scale
Standard Deviation 19.0
|
4.6 units on a scale
Standard Deviation 17.3
|
|
WOMAC Score
POD 7 Total Score
|
20.3 units on a scale
Standard Deviation 24.8
|
6.0 units on a scale
Standard Deviation 23.6
|
|
WOMAC Score
POD 14 Pain Subscore
|
6.2 units on a scale
Standard Deviation 5.0
|
4.2 units on a scale
Standard Deviation 5.4
|
|
WOMAC Score
POD 14 Stiffness Subscore
|
2.2 units on a scale
Standard Deviation 2.3
|
0.7 units on a scale
Standard Deviation 2.8
|
|
WOMAC Score
POD 28 Stiffness Subscore
|
2.5 units on a scale
Standard Deviation 2.6
|
1.7 units on a scale
Standard Deviation 2.5
|
|
WOMAC Score
POD 28 Total Score
|
36.0 units on a scale
Standard Deviation 19.3
|
29.7 units on a scale
Standard Deviation 20.2
|
|
WOMAC Score
POD 7 Pain Subscore
|
4.0 units on a scale
Standard Deviation 4.8
|
1.2 units on a scale
Standard Deviation 5.7
|
|
WOMAC Score
POD 14 Physical Function Subscore
|
22.6 units on a scale
Standard Deviation 13.6
|
14.7 units on a scale
Standard Deviation 17.6
|
|
WOMAC Score
POD 14 Total Score
|
31.1 units on a scale
Standard Deviation 19.4
|
19.6 units on a scale
Standard Deviation 24.2
|
|
WOMAC Score
POD 28 Pain Subscore
|
7.2 units on a scale
Standard Deviation 4.5
|
6.7 units on a scale
Standard Deviation 4.3
|
|
WOMAC Score
POD 28 Physical Function Subscore
|
26.2 units on a scale
Standard Deviation 14.1
|
21.2 units on a scale
Standard Deviation 14.9
|
|
WOMAC Score
POD 42 Pain Subscore
|
9.8 units on a scale
Standard Deviation 4.2
|
7.4 units on a scale
Standard Deviation 5.0
|
|
WOMAC Score
POD 42 Stiffness Subscore
|
4.2 units on a scale
Standard Deviation 1.9
|
2.8 units on a scale
Standard Deviation 2.1
|
|
WOMAC Score
POD 42 Physical Function Subscore
|
34.1 units on a scale
Standard Deviation 11.8
|
25.5 units on a scale
Standard Deviation 11.6
|
|
WOMAC Score
POD 42 Total Score
|
48.2 units on a scale
Standard Deviation 16.4
|
35.7 units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 6 weeksRate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period.
Outcome measures
| Measure |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 weekRate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery
Outcome measures
| Measure |
Exparel
n=50 Participants
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 Participants
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
|
3 Participants
|
4 Participants
|
Adverse Events
Exparel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exparel
n=50 participants at risk
Liposomal Bupivacaine use as active ingredient in the block
Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
Control
n=50 participants at risk
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
|
|---|---|---|
|
General disorders
Nausea and Vomiting
|
0.00%
0/50 • 17 months (June 2020-October 2021) Each patient was assessed for adverse events by direct history and physical exam by investigators at POD 0, POD 1, POD 2, POD 7, POD 14, POD 28, and POD 42.
Clinicaltrials.gov definitions will be used
|
8.0%
4/50 • Number of events 4 • 17 months (June 2020-October 2021) Each patient was assessed for adverse events by direct history and physical exam by investigators at POD 0, POD 1, POD 2, POD 7, POD 14, POD 28, and POD 42.
Clinicaltrials.gov definitions will be used
|
Additional Information
Dr. Chinenye Nwachuku
Saint Luke's University Health Network
Phone: 6096101054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place