Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
- Conditions
- Arthritis KneeOpioid UsePain, Postoperative
- Interventions
- Registration Number
- NCT04910165
- Lead Sponsor
- St. Luke's Hospital, Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exparel Exparel Liposomal Bupivacaine use as active ingredient in the block Control Ropivacaine Ropivacaine use as active ingredient in the block
- Primary Outcome Measures
Name Time Method Outpatient Opioid Use 6 weeks Opioid usage in the immediate post-operative period after hospital discharge
Hospital Length of Stay Through entire inpatient hospital stay (lasted from 1 day to 1 week) Inpatient post-operative stay after undergoing TKA procedure
Inpatient Opioid Use 1 week Opioid usage during their inpatient post-operative hospital stay
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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
Trial Locations
- Locations (1)
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
St. Luke's University Health Network🇺🇸Bethlehem, Pennsylvania, United States