Total Knee Arthroplasty
Conditions
Brief summary
Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.
Detailed description
The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed. Hypothesis Statement: Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.
Interventions
bupivacaine liposome suspension periarticular injection
DRUGconcentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* TKA candidacy * Osteoarthritis * Failure of non-operative treatments to control knee pain * Patients able to understand and agree to study inclusion
Exclusion criteria
* Subjects have orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease) * Severe knee deformity * Post-traumatic and inflammatory arthritis * BMI above 40 * Patients unable to receive multimodal pain remitting agents * Active knee sepsis * Remote sites of active infection * Diabetes with A1C \> 7 * ASA class \> lll * Cardiac disease failing medical clearance * Severe liver disease * PAD with AAI \< 0.75 * Seizure disorder * Allergic to any pain remitting agent * Alcohol abuse * Smoking abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (Visual Analog Pain Scores) | 1 day following surgery | visual analog pain scores (scale 0=no pain; 10=worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MS04 Equivalent Consumption | 1 day following surgery | in hospital total MS04 equivalent consumption |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Liposome Suspension bupivacaine liposome suspension periarticular injection
bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection | 35 |
| Concentrated Multi Drug Injection concentrated multi drug periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Bupivacaine Liposome Suspension | Concentrated Multi Drug Injection | Total |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 10.3 | 65.6 years STANDARD_DEVIATION 7.9 | 66.4 years STANDARD_DEVIATION 9.1 |
| Race/Ethnicity, Customized African American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 35 participants | 34 participants | 69 participants |
| Sex: Female, Male Female | 13 Participants | 20 Participants | 33 Participants |
| Sex: Female, Male Male | 22 Participants | 15 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Pain Scores (Visual Analog Pain Scores)
visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)
Time frame: 1 day following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Liposome Suspension | Pain Scores (Visual Analog Pain Scores) | 2.6 units on a scale | Standard Deviation 1.27 |
| Concentrated Multi Drug Injection | Pain Scores (Visual Analog Pain Scores) | 3.3 units on a scale | Standard Deviation 1.55 |
Secondary
MS04 Equivalent Consumption
in hospital total MS04 equivalent consumption
Time frame: 1 day following surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine Liposome Suspension | MS04 Equivalent Consumption | 10.0 mg |
| Concentrated Multi Drug Injection | MS04 Equivalent Consumption | 15.0 mg |