Clinical trial NCT03303794: 0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anesthesia
Keywords: Total Knee arthroplasty
bupivacaine
anesthesia
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: AM-PAC Score to Measure Patients Fitness for Discharge
timeFrame: Post-Operation Day 1
Secondary outcomes:
measure: Opioid Consumption During the First 48 Hours After TKA Surgery
timeFrame: During the first 48 hours after surgery
measure: Pain Scores During 48 Hrs Postoperatively
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Hutchinson Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Boleslav Kosharskyy, MD
role: PRINCIPAL_INVESTIGATOR
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