Trial | NCT02808728  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
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 Started
May 31
2014
Primary Completion
Mar 31
2015
Study Completion
Jun 30
2016
Anticipated
Last Update
Jun 22
2016
Estimate

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

Drug Pain Cocktail with Ropivacaine

pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.

Pain Cocktail with Ropivacaine 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 Exparel 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

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
No Results Posted