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

5. juli 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: (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.
Andre navne:
  • EXPAREL®
Aktiv komparator: 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.
Medicin: 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.
Andre navne:
  • Standard Periarticular Joint Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
48 Hour Post-surgical Opioid Use
Tidsramme: 48 hours
A comparison of group means between the control group and study group with regards to 48 hour opioid use.
48 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recovery Room Opioid Use
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 1 month
Examining the post-operative complication in comparison of standard knee injection post-operatively.
Up to 1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Irvine

Efterforskere

  • Ledende efterforsker: Joseph Rinehart, M.D., University of California, Irvine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

3. februar 2016

Først indsendt, der opfyldte QC-kriterier

10. februar 2016

Først opslået (Skøn)

15. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCIANES08

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Artroplastik, udskiftning, knæ

Kliniske forsøg med (Bupivacaine Liposome Injectable Suspension)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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