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

Phase 4

• Conditions: Total Knee Arthroplasty; Osteoarthritis; Pain Management
• Interventions: Drug: Pain Cocktail with Ropivacaine; Drug: Pain Cocktail with Exparel

• Registration Number: NCT02808728
• Lead Sponsor: DeClaire LaMacchia Orthopaedic Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-05
• Primary Completion: 2015-03
• Status Verified: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-22
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Cocktail with Ropivacaine	Pain Cocktail with Ropivacaine	patients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation. given in one single dose
Pain Cocktail with Exparel	Pain Cocktail with Exparel	patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc. given in one single dose

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	immediately post-operatively through hospital stay	oral and intravenous narcotic consumption is recorded during hospital stay

Secondary Outcome Measures

Name	Time	Method
Hours to ambulate 100 feet	immediately post-operatively through hospital stay
Length of hospital stay (hours)	immediately post-operatively through hospital stay	Number of hours the patient stays at the hospital following operation
Visual Analog Pain Score	day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively
Knee Society Score	3 months, 6 months, 1 year postoperatively