Arthritis Knee, Opioid Use, Pain, Postoperative
Conditions
Keywords
Exparel, adductor, knee, arthroplasty, opioid
Brief summary
Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.
Detailed description
The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.
Interventions
DRUGExparel
Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
DRUGRopivacaine
Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Sponsors
St. Luke's Hospital, Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.
Exclusion criteria
* Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Opioid Use | 1 week | Opioid usage during their inpatient post-operative hospital stay |
| Outpatient Opioid Use | 6 weeks | Opioid usage in the immediate post-operative period after hospital discharge |
| WOMAC Score | 6 weeks | 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. |
| Hospital Length of Stay | Through entire inpatient hospital stay (lasted from 1 day to 1 week) | Inpatient post-operative stay after undergoing TKA procedure |
| Numeric Rating Scale (NRS) Pain Score Improvement | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively | 1 week | Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery |
| Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively | 6 weeks | Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control | Total | Exparel |
|---|---|---|---|
| Age, Continuous | 66.2 years | 66.2 years | 66.1 years |
| American Society of Anesthesiology (ASA) Score ASA 2 | 26 Participants | 52 Participants | 26 Participants |
| American Society of Anesthesiology (ASA) Score ASA 3 | 24 Participants | 48 Participants | 24 Participants |
| BMI | 32.3 kg/m^2 | 32.25 kg/m^2 | 32.2 kg/m^2 |
| Kellgren and Lawrence Osteoarthritis Grade 2 | 9 Participants | 14 Participants | 5 Participants |
| Kellgren and Lawrence Osteoarthritis Grade 3 | 24 Participants | 53 Participants | 29 Participants |
| Kellgren and Lawrence Osteoarthritis Grade 4 | 17 Participants | 33 Participants | 16 Participants |
| Previous Surgery No | 39 Participants | 73 Participants | 34 Participants |
| Previous Surgery Yes | 11 Participants | 27 Participants | 16 Participants |
| Previous TKA No | 41 Participants | 81 Participants | 40 Participants |
| Previous TKA Yes | 9 Participants | 19 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 29 Participants | 54 Participants | 25 Participants |
| Sex: Female, Male Male | 21 Participants | 46 Participants | 25 Participants |
| Smoking No | 41 Participants | 81 Participants | 40 Participants |
| Smoking Yes | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 4 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Hospital Length of Stay
Inpatient post-operative stay after undergoing TKA procedure
Time frame: Through entire inpatient hospital stay (lasted from 1 day to 1 week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel | Hospital Length of Stay | 36.3 Hours | Standard Deviation 12.4 |
| Control | Hospital Length of Stay | 49.7 Hours | Standard Deviation 35.3 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Inpatient Opioid Use
Opioid usage during their inpatient post-operative hospital stay
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel | Inpatient Opioid Use | 40.9 Milimorphine Equivalents/Day | Standard Deviation 20.7 |
| Control | Inpatient Opioid Use | 47.3 Milimorphine Equivalents/Day | Standard Deviation 27.9 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Numeric Rating Scale (NRS) Pain Score Improvement
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 2 | 2.3 units on a scale | Standard Deviation 2.6 |
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 14 | 3.2 units on a scale | Standard Deviation 3.2 |
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 1 | 1.0 units on a scale | Standard Deviation 2.7 |
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 28 | 3.9 units on a scale | Standard Deviation 2.6 |
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 7 | 1.8 units on a scale | Standard Deviation 3.5 |
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 42 | 5.2 units on a scale | Standard Deviation 2.7 |
| Exparel | Numeric Rating Scale (NRS) Pain Score Improvement | POD 0 | 1.8 units on a scale | Standard Deviation 2.7 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 42 | 3.0 units on a scale | Standard Deviation 2.5 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 0 | -0.2 units on a scale | Standard Deviation 2.7 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 1 | -1.3 units on a scale | Standard Deviation 2.4 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 2 | -0.1 units on a scale | Standard Deviation 2.3 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 7 | 0.2 units on a scale | Standard Deviation 2.9 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 14 | 1.3 units on a scale | Standard Deviation 3 |
| Control | Numeric Rating Scale (NRS) Pain Score Improvement | POD 28 | 2.2 units on a scale | Standard Deviation 2.9 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Outpatient Opioid Use
Opioid usage in the immediate post-operative period after hospital discharge
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel | Outpatient Opioid Use | 33.4 Milimorphine Equivalents/Day | Standard Deviation 11.6 |
| Control | Outpatient Opioid Use | 32.1 Milimorphine Equivalents/Day | Standard Deviation 13.2 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
WOMAC Score
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exparel | WOMAC Score | POD 7 Pain Subscore | 4.0 units on a scale | Standard Deviation 4.8 |
| Exparel | WOMAC Score | POD 7 Stiffness Subscore | 1.5 units on a scale | Standard Deviation 2.7 |
| Exparel | WOMAC Score | POD 7 Physical Function Subscore | 14.8 units on a scale | Standard Deviation 19 |
| Exparel | WOMAC Score | POD 7 Total Score | 20.3 units on a scale | Standard Deviation 24.8 |
| Exparel | WOMAC Score | POD 14 Pain Subscore | 6.2 units on a scale | Standard Deviation 5 |
| Exparel | WOMAC Score | POD 14 Stiffness Subscore | 2.2 units on a scale | Standard Deviation 2.3 |
| Exparel | WOMAC Score | POD 14 Physical Function Subscore | 22.6 units on a scale | Standard Deviation 13.6 |
| Exparel | WOMAC Score | POD 14 Total Score | 31.1 units on a scale | Standard Deviation 19.4 |
| Exparel | WOMAC Score | POD 28 Pain Subscore | 7.2 units on a scale | Standard Deviation 4.5 |
| Exparel | WOMAC Score | POD 28 Stiffness Subscore | 2.5 units on a scale | Standard Deviation 2.6 |
| Exparel | WOMAC Score | POD 28 Physical Function Subscore | 26.2 units on a scale | Standard Deviation 14.1 |
| Exparel | WOMAC Score | POD 28 Total Score | 36.0 units on a scale | Standard Deviation 19.3 |
| Exparel | WOMAC Score | POD 42 Pain Subscore | 9.8 units on a scale | Standard Deviation 4.2 |
| Exparel | WOMAC Score | POD 42 Stiffness Subscore | 4.2 units on a scale | Standard Deviation 1.9 |
| Exparel | WOMAC Score | POD 42 Physical Function Subscore | 34.1 units on a scale | Standard Deviation 11.8 |
| Exparel | WOMAC Score | POD 42 Total Score | 48.2 units on a scale | Standard Deviation 16.4 |
| Control | WOMAC Score | POD 42 Total Score | 35.7 units on a scale | Standard Deviation 17.1 |
| Control | WOMAC Score | POD 7 Pain Subscore | 1.2 units on a scale | Standard Deviation 5.7 |
| Control | WOMAC Score | POD 28 Pain Subscore | 6.7 units on a scale | Standard Deviation 4.3 |
| Control | WOMAC Score | POD 7 Stiffness Subscore | 0.2 units on a scale | Standard Deviation 2.8 |
| Control | WOMAC Score | POD 42 Pain Subscore | 7.4 units on a scale | Standard Deviation 5 |
| Control | WOMAC Score | POD 7 Physical Function Subscore | 4.6 units on a scale | Standard Deviation 17.3 |
| Control | WOMAC Score | POD 28 Stiffness Subscore | 1.7 units on a scale | Standard Deviation 2.5 |
| Control | WOMAC Score | POD 7 Total Score | 6.0 units on a scale | Standard Deviation 23.6 |
| Control | WOMAC Score | POD 42 Physical Function Subscore | 25.5 units on a scale | Standard Deviation 11.6 |
| Control | WOMAC Score | POD 14 Pain Subscore | 4.2 units on a scale | Standard Deviation 5.4 |
| Control | WOMAC Score | POD 28 Physical Function Subscore | 21.2 units on a scale | Standard Deviation 14.9 |
| Control | WOMAC Score | POD 14 Stiffness Subscore | 0.7 units on a scale | Standard Deviation 2.8 |
| Control | WOMAC Score | POD 42 Stiffness Subscore | 2.8 units on a scale | Standard Deviation 2.1 |
| Control | WOMAC Score | POD 14 Physical Function Subscore | 14.7 units on a scale | Standard Deviation 17.6 |
| Control | WOMAC Score | POD 28 Total Score | 29.7 units on a scale | Standard Deviation 20.2 |
| Control | WOMAC Score | POD 14 Total Score | 19.6 units on a scale | Standard Deviation 24.2 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively | 3 Participants |
| Control | Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively | 4 Participants |
p-value: <0.05Fisher Exact
Secondary
Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively | 2 Participants |
| Control | Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively | 6 Participants |
p-value: <0.05Fisher Exact