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Dexamethasone in Total Knee and Total Hip Arthroplasty

21. november 2017 opdateret af: University Health Network, Toronto

Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?

This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The addition of dexamethasone to an local infiltration analgesia (LIA) mixture for postoperative analgesia following total knee arthroplasty (TKA) has a limited evidence base. Although there is increasing support in the literature for its use in peripheral nerve blockade, there have only been a handful of studies assessing its applicability in periarticular LIA. Moreover, the evidence from peripheral nerve blocks suggests that one of the key benefits of dexamethasone is a prolongation of nerve blockade. Additionally, dexamethasone has been shown to prolong the local analgesic effect of bupivacaine microcapsules.

With respect to total hip arthroplasty (THA), there have only been two small studies that included corticosteroids in the LIA mixture; there was analgesic benefit and better early rehabilitation outcomes when compared to placebo. However, there is limited high-quality evidence for either THA or TKA demonstrating an improvement in functional outcomes when dexamethasone is used in an LIA mixture. This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

314

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Rekruttering
        • Toronto Western Hopspital
        • Ledende efterforsker:
          • Vincent Chan, MD. FRCPC

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 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Undergoing elective, primary, unilateral total hip or knee arthroplasty under spinal anesthesia
  • ASA-PS I-III
  • 18-85 years of age, inclusive
  • 50-100 kg, inclusive
  • BMI 18 - 40

Exclusion Criteria:

  • Revision hip/knee arthroplasty
  • Bilateral hip/knee arthroplasty
  • Inability or refusal to provide informed consent
  • Any contraindication to spinal anesthesia (e.g., bleeding diathesis, infection, neuropathy)
  • Allergy to local anesthesia, ketorolac or dexamethasone
  • Allergy to opioids
  • Chronic pain state, neuropathic pain
  • Opioid dependence
  • Diabetic patients will NOT be excluded except those with significant peripheral neuropathy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
Medicin: Dexamethasone
8mg (2mL) of Dexamethasone added to standard LIA mixture
Andre navne:
  • Baycadron
Medicin: LIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
Sham-komparator: Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
Medicin: LIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
Andet: 0.9% NaCl Placebo
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
Andre navne:
  • Saltvand

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
Tidsramme: 3 days - post operative
3 days - post operative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Analgesic outcomes- pain
Tidsramme: 3 days - post operative

Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points:

  1. The post-anesthetic care unit (PACU)
  2. Postoperative day (POD) 1 at rest between 8-10 AM
  3. POD1 during physiotherapy
  4. POD 2 at rest between 8 -10 AM
  5. POD 2 during physiotherapy

g. POD 3 during physiotherapy if still in hospital
3 days - post operative
Analgesic outcomes- opiate consumption
Tidsramme: 3 days - post operative
Cumulative systemic opioid consumption measured as oral morphine mg equivalents on POD 1, POD2, and, if still in hospital, POD 3, as well as the proportion of patients who required "rescue" intravenous patient controlled analgesia (IV PCA) anytime in the postoperative period
3 days - post operative
Analgesic outcomes- TUG test
Tidsramme: 3 days - post operative
Timed Up and Go Test (TUG) on postoperative days 2 or 3
3 days - post operative
Analgesic outcomes- Drug side-effects
Tidsramme: 3 days - post operative

Incidence of opioid-related side effects:

  1. Nausea and vomiting requiring treatment with anti-emetic
  2. Pruritus requiring treatment with antihistamines
  3. Sedation requiring treatment with opioid antagonist
3 days - post operative
Short-term physical and performance-based functional outcome measures- in hospital complications
Tidsramme: 3 days post operative
In-hospital complications- Any outcomes such as MI, surgical site infection, neurological complications, etc. that may have occurred during the hospital stay
3 days post operative
Short-term physical and performance-based functional outcome measures- length of stay
Tidsramme: 3 days - post operative
Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery
3 days - post operative
Short-term physical and performance-based functional outcome measures- discharge
Tidsramme: 3 days - post operatively
Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre
3 days - post operatively
Medium-term self-reported functional outcome measures- WOMAC
Tidsramme: 3 months- post operative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
3 months- post operative
Medium-term self-reported functional outcome measures- LFES
Tidsramme: 3 months- post operative
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively
3 months- post operative

Samarbejdspartnere og efterforskere

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

Sponsor

University Health Network, Toronto

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. april 2016

Primær færdiggørelse (Forventet)

1. oktober 2018

Studieafslutning (Forventet)

1. oktober 2018

Datoer for studieregistrering

Først indsendt

14. april 2016

Først indsendt, der opfyldte QC-kriterier

29. april 2016

Først opslået (Skøn)

3. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UHN15-9898-A

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Undecided at this moment.

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