Osteoarthritis, Pain, Postoperative
Conditions
Keywords
primary total knee arthroplasty, liposomal bupivacaine
Brief summary
The purpose of this study is to compare the efficacy and duration of pain relief after total knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to discharge readiness.
Interventions
DRUGLiposomal bupivacaine
Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection.
DRUGBupivacaine plus dexamethasone
Bupivacaine HCl 0.5% 10 mL plus dexamethasone 2 mg for quadriceps sparing femoral nerve block and bupivacaine HCl 0.25% plus dexamethasone 2 mg for posterior knee compartment periarticular injection
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients of American Society of Anesthesiologist (ASA) I-III physical class with a pre-operative diagnosis of primary osteoarthritis scheduled for elective primary total knee arthroplasty. * Patients must be living independently at home prior to undergoing primary total knee arthroplasty with intention of discharge directly to home after hospitalization
Exclusion criteria
* Subjects will not be eligible for this trial if they have a history of allergy to a local anesthetic * Known peripheral neuropathy * Known connective tissue or immunological disorders * Stroke or other known central nervous system disorders * Renal dysfunction * Hepatic dysfunction * Cardiac dysfunction other than hypertension * Pregnant subjects * Immunosuppression * Human immunodeficiency virus (HIV) * Alcohol or drug abuse * Chronic pain or opioid dependence * Coagulopathy or those unable to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of rehabilitative goals | Time until discharge (up to 2 weeks) | Assessment of temporal achievement of rehabilitative goals for discharge (independent ambulation to 100 feet, stair climbing, timed-up-and-go, independent toileting, ability to get dressed independently, capacity to get in and out of bed, capability to sit and rise from a chair/toilet, independence in personal care, mobilization with walker/crutches, and NRS\<5 on activity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively) | Throughout admission (up to 2 weeks) | Assessment of mean post-operative pain using a Numeric rating scale (NRS)- both at rest and during active knee flexion to 45 degree at 24, 48 and 72 hours post-operatively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean length of stay in days | Through study completion (up to 2 weeks) | — |
| Time to first use of postsurgical opioid medication | Up to 24 hours postoperatively | — |
| Proportion of patients receiving no post-surgery rescue opioid medication | 0, 6, 12, 24 and 72 hours postoperatively | — |
| Discharge to home versus rehabilitation services among the comparison cohorts | Up to hospital discharge (up to 2 weeks) | — |
| Total cost comparisons between the two cohorts | Up to hospital discharge (up to 2 weeks) | Including medications, nursing care costs, operating room costs, rehabilitation costs |
| Cumulative pain score assessment | 24, 48 and 72 hours postoperatively | Assessment of cumulative pain score reflected by area under the curve (AUC) for NRS scores through 12, 24, 36, 48, 60, and 72 hrs. |
| Functional outcomes | At 6 weeks, 3 months, 6 months and 1 year postoperatively | Functional outcomes following total knee arthroplasty at 6 weeks, 3 months, 6 months, 1 year using the Knee Society Score. |
| Activity levels | At 6 weeks, 3 months, 6 months and 1 year postoperatively | Activity levels following total knee arthroplasty at 6 weeks, 3 months, 6 months, and 1 year using the University of California Los Angeles scores |
| Objective quadriceps strength assessment | At 24 hours postoperatively | Objective quadriceps strength assessment using a Biodex isokinetic dynamometer at 24 hours post-operatively and at the time of discharge |
| Patient perceived health outcomes | 6 weeks, 3 months, 6 months, and up to 1 year | Patient perceived health outcomes at 6 weeks, 3 months, 6 months, and up to 1 year using Short Form-36 scores |
| Evaluate and observe any adverse reactions and complications | From time of randomization through study completion (up to 1 year) | — |
| Quality of recovery assessment | Postoperatively at day 0, 1, 2 and prior to discharge (up to 2 weeks) | — |
| Mean daily Opioid consumption | 24, 48, 72 hours post-operatively, and until discharge (up to 2 weeks) | Mean daily opioid consumption as morphine equivalents using the online calculator http://www.nyc.gov/html/doh/html/mental/MME.html |
Countries
United States
Outcome results
None listed