0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
NCT ID: NCT03303794
Last Updated: 2020-03-20
Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-25
Study Completion Date
2018-06-27
Brief Summary
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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 participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.
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Detailed Description
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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 the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies:
1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and
2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.
1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and
2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.
Conditions
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Anesthesia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Bupivicaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
Group Type
ACTIVE_COMPARATOR
0.25% bupivacaine
Intervention Type
DRUG
0.25% bupivacaine in patients undergoing total knee arthroplasty
Bupivicaine + Exparel
0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
Group Type
EXPERIMENTAL
Exparel
Intervention Type
DRUG
1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
0.25% bupivacaine
Intervention Type
DRUG
0.25% bupivacaine in patients undergoing total knee arthroplasty
Interventions
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Exparel
1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
Intervention Type
DRUG
0.25% bupivacaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
Intervention Type
DRUG
Other Intervention Names
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liposomal
Eligibility Criteria
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Inclusion Criteria
* 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
* Ages 40- 80 years old
* American Society of Anesthesiologists class I-III
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Montefiore Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Singh Nair
Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Boleslav Kosharskyy, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Hutchinson Campus
The Bronx, New York, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-7893
Identifier Type: -
Identifier Source: org_study_id
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