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

Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Pain Management; Total Knee Arthroplasty
• Intervention / Treatment: Drug: Pain Cocktail with Ropivacaine; Drug: Pain Cocktail with Exparel

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Pain Cocktail with Ropivacaine; pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
Experimental: 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	Drug: Pain Cocktail with Exparel; 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.; Other Names: liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	oral and intravenous narcotic consumption is recorded during hospital stay	immediately post-operatively through hospital stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hours to ambulate 100 feet		immediately post-operatively through hospital stay
Length of hospital stay (hours)	Number of hours the patient stays at the hospital following operation	immediately post-operatively through hospital stay
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

Collaborators and Investigators

• Sponsor: DeClaire LaMacchia Orthopaedic Institute
• Investigators: Study Director: Olayinka Warritay, MD, DeClaire LaMacchia Orthopaedic Institute

Publications and helpful links

General Publications

• DeClaire JH, Aiello PM, Warritay OK, Freeman DC. Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study. J Arthroplasty. 2017 Sep;32(9S):S268-S271. doi: 10.1016/j.arth.2017.03.062. Epub 2017 Apr 6.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Estimate): June 22, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Ropivacaine; Liposomal Bupivacaine; Total Knee Replacement; Exparel; Postoperative Pain Management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: WIRB 20131914