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Completed

NCT Number: NCT02682498

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(Bupivacaine Liposome Injectable Suspension)

Drug

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®

Standard Preparation

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 15, 2016
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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