Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty

DeClaire LaMacchia Orthopaedic Institute100 enrolled

Overview

Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach? The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.

The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Osteoarthritis Total Knee Arthroplasty Pain Management

Interventions

Pain Cocktail with ExparelDRUG

pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.

Pain Cocktail with RopivacaineDRUG

pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire * 18 years of age or older * Primary diagnosis of osteoarthritis of the knee * Opioid naïve patient (according to FDA guidelines) Exclusion Criteria: * Prior knee replacement * Prior use of narcotics for chronic pain management * Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.) * Unicompartmental knee replacement * Bilateral Total Knee Arthroplasty * Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least: \> 60 mg oral morphine/day \> 25μg transdermal fentanyl/hour \> 30 mg oral oxycodone/day \> 8 mg oral hydromorphone/day \> 25 mg oral oxymorphone/day

Outcomes

Primary Outcomes

Postoperative opioid consumption

oral and intravenous narcotic consumption is recorded during hospital stay

Time frame: immediately post-operatively through hospital stay

Secondary Outcomes

Hours to ambulate 100 feet

Time frame: immediately post-operatively through hospital stay

Length of hospital stay (hours)

Number of hours the patient stays at the hospital following operation

Time frame: immediately post-operatively through hospital stay

Visual Analog Pain Score

Time frame: day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively

Knee Society Score

Time frame: 3 months, 6 months, 1 year postoperatively