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

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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

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Drug: (Bupivacaine Liposome Injectable Suspension) Drug: Standard Preparation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections
Study Start Date : October 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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 Name: Standard Periarticular Joint Injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Post-operative Complications [ Time Frame: Up to 1 month ]
    Examining the post-operative complication in comparison of standard knee injection post-operatively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682498


Locations
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United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Joseph Rinehart, M.D. University of California, Irvine
Publications:

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Responsible Party: Joseph Brian Rinehart, Assistant Professor of Clinical Anesthesiology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02682498    
Other Study ID Numbers: UCIANES08
First Posted: February 15, 2016    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joseph Brian Rinehart, University of California, Irvine:
Knee Arthroplasty, Total
Liposomal Bupivicaine
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents