N/A
N=70
Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection
Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT02299349 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Pain Scores (Visual Analog Pain Scores) — 2.6; 3.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- bupivacaine liposome suspension (Drug); concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- TriHealth Inc.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores (Visual Analog Pain Scores) |
2.6; 3.3 | — |
| SECONDARY MS04 Equivalent Consumption |
10.0; 15.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02299349). 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.