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

July 5, 2017 updated by: Joseph Brian Rinehart, University of California, Irvine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and Females age 18+ years old having total knee arthroplasty at UCI
  • Meet at least one of the following criteria "opioid tolerant":
  • Taking 50mg oral morphine equivalent or more per day
  • On long-acting opioids (fentanyl pathc, oxycontin, methadone, etc.)
  • Being followed by a chronic pain physician
  • All subjects must be free of renal or hepatic dysfunction; defined as:
  • Glomerular filtration rate >60 mL/min/1.73m^2
  • AST & ALT <150, total bilirubin <1.0, INR <1.3 (if not taking anticoagulants)
  • No active hepatitis, no jaundice

Control group- received standard periarticular injection Research group- receives Exparel injection

Exclusion Criteria:

  • Allergy to local Anesthetic
  • Pregnancy
  • Nursing mothers
  • Children<18 years of age
  • Renal impairment (GFR<60 mL/min/1.73 m^2
  • Hepatic impairment (active hepatitis, elevated AST or ALT, jaundice)
  • Any history of ventricular arrhythmia or supraventricular tachycardia, or myocardial infarction within the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EXPAREL® Bupivacaine Liposome Suspension
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
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.
Other Names:
  • EXPAREL®
Active Comparator: Standard periarticular joint injection
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.
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.
Other Names:
  • Standard Periarticular Joint Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
48 Hour Post-surgical Opioid Use
Time Frame: 48 hours
A comparison of group means between the control group and study group with regards to 48 hour opioid use.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Room Opioid Use
Time Frame: Up to 48 hours
Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.
Up to 48 hours
Average Daily Opioid Use During Admission
Time Frame: Up to 48 hours
Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.
Up to 48 hours
Average Daily Patient Pain Score
Time Frame: Up to 48 hours
Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.
Up to 48 hours
Post-operative Complications
Time Frame: Up to 1 month
Examining the post-operative complication in comparison of standard knee injection post-operatively.
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Joseph Rinehart, M.D., University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCIANES08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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