Status:
TERMINATED
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
Lead Sponsor:
Montefiore Medical Center
Conditions:
Anesthesia
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as p...
Detailed Description
This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is ...
Eligibility Criteria
Inclusion
- All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis
- Ages 40- 80 years old
- American Society of Anesthesiologists class I-III
Exclusion
- Refusal or absolute medical contraindication to peripheral nerve block
- refusal or absolute medical contraindication to spinal anesthesia
- conversion of spinal anesthesia to general anesthesia is obtained
- inability to cooperate
- allergy to any drug used in this study
- daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)
- alcohol dependence or use of any illegal drugs within the last month
- inability to perform the mobilization test and timed up and go (TUG) test pre-operatively
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03303794
Start Date
October 25 2017
End Date
June 27 2018
Last Update
March 20 2020
Active Locations (1)
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1
Montefiore Hutchinson Campus
The Bronx, New York, United States, 10461