N/A
Completed N=60
Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT02219087 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Number Physical Therapy Sessions Necessary for Discharge — 3.0; 3.6 Physical Therapy Sessions — p=0.137
Summary
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Physical Therapy Sessions Necessary for Discharge |
3.0; 3.6 | 0.137 |
| SECONDARY Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay |
4.4; 4.7 | 0.343 |
| SECONDARY Length of Stay (LOS, in Days) |
2.5; 2.3 | 0.208 |
| SECONDARY Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams) |
274.6; 304.8 | 0.385 |
| SECONDARY Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay |
13; 11 | 0.843 |
| SECONDARY Total Cost of Care (Dollars) |
64582.90; 62601.50 | 0.438 |
| SECONDARY Hospital Readmission Not Including Admissions Planned Procedures |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator
Exclusion Criteria
- Age <18 years
- Pregnant or breastfeeding
- Non-English-speaking
- Unable to give informed consent
- Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
- Patients unable to complete a device-assisted 140 foot walk at baseline
- Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
- Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
- Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)
Data sourced from ClinicalTrials.gov (NCT02219087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.