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Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

15. december 2012 opdateret af: Tae Kyun Kim, Seoul National University Hospital

Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republikken, 463-707
        • Joint Reconstruction Center, Seoul National University Bundang Hospital

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 til 81 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of primary osteoarthritis
  • Scheduled for elective total knee arthroplasty
  • Signed written informed consent
  • Spinal anesthesia

Exclusion Criteria:

  • Patients refusing consents
  • inability to use the outcome assessment tools
  • Contraindications to regional anesthesia
  • severe cardiovascular disease
  • allergy or contraindication to drugs used in this study
  • pre-existing neurologic disease including psychiatric disorder
  • drug abuser

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
Eksperimentel: Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Medicin: ropivacaine
300mg (0.75%, 40cc) intraoperative periarticular injection
Medicin: morphine sulfate
10mg intraoperative periarticular injection
Medicin: ketorolac
30 mg intraoperative periarticular injection
Medicin: epinephrine
300 microgram (1:1000) intraoperative periarticular injection
Medicin: cefuroxime
750mg intraoperative periarticular injection
Ingen indgriben: No Injection group
usual postoperative care without periarticular injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain( Visual Analog Scale )
Tidsramme: the night after surgery
An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.
the night after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Tidsramme: 24 hours postoperative
Fentanyl based PCA consumption via PCA pump (microgram)
24 hours postoperative
Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery
Tidsramme: 24 hours after surgery
An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.
24 hours after surgery
the Proportion of Patients Who Were Satisfied With the Pain Management
Tidsramme: postoperative 7 day
postoperative 7 day
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
Tidsramme: 24 hours postoperative
24 hours postoperative
Maximal Flexion Angle Degree on Postoperative 7 Day
Tidsramme: postoperative 7 day
An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day
postoperative 7 day

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University Hospital

Efterforskere

  • Ledende efterforsker: Tae Kyun Kim, MD, PhD, Joint Recontruction Center, Seoul National University Bundang hospital

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. april 2008

Primær færdiggørelse (Faktiske)

1. marts 2009

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

13. maj 2009

Først indsendt, der opfyldte QC-kriterier

13. maj 2009

Først opslået (Skøn)

14. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2012

Sidst verificeret

1. december 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B-0804/056-021

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Slidgigt, knæ

Kliniske forsøg med ropivacaine

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner