0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka

Montefiore Medicine Academic Health System

Status and phase

Terminated

Phase 3

Conditions

Anesthesia

Treatments

Drug: 0.25% bupivacaine

Drug: Exparel

Study type

Interventional

Funder types

Other

Identifiers

NCT03303794

2017-7893

Details and patient eligibility

About

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.

Full 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:

Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and
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.

Enrollment

25 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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