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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682498
Recruitment Status : Completed
First Posted : February 15, 2016
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Brian Rinehart, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE February 3, 2016
First Posted Date  ICMJE February 15, 2016
Results First Submitted Date  ICMJE October 31, 2016
Results First Posted Date  ICMJE July 7, 2017
Last Update Posted Date July 7, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
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. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • 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.
  • 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.
  • 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.
  • Post-operative Complications [ Time Frame: Up to 1 month ]
    Examining the post-operative complication in comparison of standard knee injection post-operatively.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • PACU opioid use [ Time Frame: Up to 72 hours ]
    PACU opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.
  • Average Daily Opioid Use During Admission [ Time Frame: Up to 72 hours ]
    Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.
  • Length of stay [ Time Frame: Up to 72 hours ]
    The duration of length of stay for the patient in comparison of standard knee injection post-operatively.
  • Average Daily Patient Pain Score [ Time Frame: Up to 72 hours ]
    Examining the average daily patient pain score in comparison of standard knee injection post-operatively.
  • Post-operative Complications [ Time Frame: Up to 1 month ]
    Examining the post-operative complication in comparison of standard knee injection post-operatively.
  • Total walking distance (feet) during physical therapy [ Time Frame: Up to 1 month ]
    Sum of total distance walked during PT on each post-operative day.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
Official Title  ICMJE A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Knee
Intervention  ICMJE
  • 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 Name: EXPAREL®
  • 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 Name: Standard Periarticular Joint Injection
Study Arms  ICMJE
  • 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.
    Intervention: Drug: (Bupivacaine Liposome Injectable Suspension)
  • 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.
    Intervention: Drug: Standard Preparation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2017)
38
Original Actual Enrollment  ICMJE
 (submitted: February 10, 2016)
35
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682498
Other Study ID Numbers  ICMJE UCIANES08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joseph Brian Rinehart, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Rinehart, M.D. University of California, Irvine
PRS Account University of California, Irvine
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP