Overview

This trial is active, not recruiting.

Conditions osteoarthritis, total knee arthroplasty, pain management
Treatments pain cocktail with exparel, pain cocktail with ropivacaine
Phase phase 4
Sponsor DeClaire LaMacchia Orthopaedic Institute
Start date May 2014
End date March 2015
Trial size 100 participants
Trial identifier NCT02808728, WIRB 20131914

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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 ropivacaine
pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
(Experimental)
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
pain cocktail with exparel liposomal bupivacaine
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.

Primary Outcomes

Measure
Postoperative opioid consumption
time frame: immediately post-operatively through hospital stay

Secondary Outcomes

Measure
Hours to ambulate 100 feet
time frame: immediately post-operatively through hospital stay
Length of hospital stay (hours)
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by DeClaire LaMacchia Orthopaedic Institute.