Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty
Completed · Not applicable
Conditions studied: Osteoarthritis, Knee
In brief
The purpose of this study is to determine quantitative and qualitative differences in post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who receive administration of a newly approved, long acting local anesthetic branded as ExparelTM (bupivacaine liposome injectable suspension) introduced by one of two different administration methods. Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly into the joint capsule at the conclusion of the surgery, effectively bathing the joint in anesthetic solution. Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9) standard sites at the conclusion of the surgery.
Key facts
- Study ID
- NCT02166632
- Run by
- Broward Health
- People needed
- 50
- Starts
- 2014-04-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2016-02-10
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be over the age of 18
- Patients must have a preoperative diagnosis of osteoarthritis of the knee requiring total knee arthroplasty
You may not qualify if…
- Allergy to ExparelTM or certain other local anesthetic agents
- Pregnant females or females who think they may become pregnant
- Markedly abnormal kidney function or renal disease
- History of substance abuse
- History of chronic pain requiring medication
- Had a previous total knee arthroplasty on the same knee which is being replaced (revision total knee arthroplasty)
- Had a previous partial knee arthroplasty, such as a unicompartmental knee arthroplasty on the same knee (also a revision total knee arthroplasty)
Where it is running
- Broward Health Sports Medicine — Fort Lauderdale, Florida, United States
Full record on ClinicalTrials.gov
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