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 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.
Brief Title
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
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 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.
Completion Date
Completion Date Type
Actual
Conditions
Anesthesia
Eligibility Criteria
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
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
* 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 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Total Knee arthroplasty
bupivacaine
anesthesia
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
40 Years
NCT Id
NCT03303794
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-7893
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study
Primary Outcomes
Outcome Description
AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.
Outcome Measure
AM-PAC Score to Measure Patients Fitness for Discharge
Outcome Time Frame
Post-Operation Day 1
Secondary Outcomes
Outcome Description
Monitor how much opioid patient consumes
Outcome Time Frame
During the first 48 hours after surgery
Outcome Measure
Opioid Consumption During the First 48 Hours After TKA Surgery
Outcome Description
Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.
Outcome Time Frame
48 hours postoperatively
Outcome Measure
Pain Scores During 48 Hrs Postoperatively
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Boleslav Kosharskyy
Investigator Email
bkoshars@montefiore.org
Investigator Phone
MeSH Terms
BUPIVACAINE
LIPOSOMES
ANILIDES
AMIDES
ORGANIC CHEMICALS
ANILINE COMPOUNDS
AMINES
MEMBRANES, ARTIFICIAL
BIOMEDICAL AND DENTAL MATERIALS
DRUG CARRIERS
DOSAGE FORMS
PHARMACEUTICAL PREPARATIONS
MANUFACTURED MATERIALS
TECHNOLOGY, INDUSTRY, AND AGRICULTURE
BIOMIMETIC MATERIALS