Status:
COMPLETED
Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
Lead Sponsor:
OhioHealth
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
Detailed Description
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its u...
Eligibility Criteria
Inclusion
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
Exclusion
- Age \< 18 years
- Pregnant or breastfeeding
- Non-English speaking
- Unable to give informed consent
- Previous open hip, knee or shoulder surgery
- Pre-determined patients discharging to ECF
- Patients with allergies to bupivacaine
- Patients currently taking opioid pain medication
- Patients with contraindication to nerve blocks
- Patients undergoing simultaneous bilateral joint replacement, as this would require \>1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- Patients with severe hepatic disease
- Patients with chronic heart disease as defined as a decreased ejection fraction
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT02197273
Start Date
July 1 2014
End Date
October 1 2015
Last Update
October 21 2016
Active Locations (1)
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1
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214