NCT02682498

Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj

A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.

Detailed description

Opioids have been prescribed with increasing frequency for non-acute, non-cancer pain in the last 15 years. Because of this, opioid tolerance in the general population has grown markedly, and opioid tolerant patients can be especially difficult to manage in the perioperative period. In general, they require much higher doses of opioids to obtain similar levels of pain-control compared to opioid-naïve patients and are susceptible to respiratory depression and other adverse events. This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DRUG	(Bupivacaine Liposome Injectable Suspension)	Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
DRUG	Standard Preparation	A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2016-02-15
• Last updated: 2017-07-07
• Results posted: 2017-07-07

Locations

1 site across 1 country: United States