Clinical trial NCT02808728: Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Total Knee Arthroplasty
Pain Management
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Exparel
Liposomal Bupivacaine
Ropivacaine
Postoperative Pain Management
Lead sponsor: DeClaire LaMacchia Orthopaedic Institute
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: immediately post-operatively through hospital stay
Secondary outcomes:
measure: Hours to ambulate 100 feet
timeFrame: immediately post-operatively through hospital stay
measure: Length of hospital stay (hours)
timeFrame: immediately post-operatively through hospital stay
measure: Visual Analog Pain Score
timeFrame: day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively
measure: Knee Society Score
timeFrame: 3 months, 6 months, 1 year postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: DeClaire LaMacchia Orthopaedic Institute
name: Olayinka Warritay, MD
role: STUDY_DIRECTOR
References:
citation: 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.