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

DeClaire LaMacchia Orthopaedic Institute

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis; Pain Management; Total Knee Arthroplasty

Treatments: Drug: Pain Cocktail with Ropivacaine; Drug: Pain Cocktail with Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT02808728

WIRB 20131914

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Pain Cocktail with Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Pain Cocktail with Ropivacaine

Pain Cocktail with Exparel

Experimental group

Description:

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

Treatment:

Drug: Pain Cocktail with Exparel