Status:
COMPLETED
Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection
Lead Sponsor:
TriHealth Inc.
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
35-90 years
Phase:
NA
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 furt...
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 adve...
Eligibility Criteria
Inclusion
- TKA candidacy
- Osteoarthritis
- Failure of non-operative treatments to control knee pain
- Patients able to understand and agree to study inclusion
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02299349
Start Date
August 1 2013
End Date
March 1 2014
Last Update
October 9 2018
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