Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty
NCT02166632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2016-02-10
Summary
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.
Conditions
- Osteoarthritis, Knee
Interventions
- PROCEDURE
-
Intracapsular Injection
The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively "bathing" the joint in the medication.
- PROCEDURE
-
Periarticular Injection
The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint
Sponsors & Collaborators
-
Broward Health
lead OTHER
Principal Investigators
-
William V Burke, M.D. · Broward Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- United States
Study Locations
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