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Dexamethasone in Total Knee and Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02760043
Recruitment Status : Unknown
Verified November 2017 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Total Hip Arthroplasty Osteoarthritis Drug: Dexamethasone Other: 0.9% NaCl Placebo Drug: LIA Combination Mixture Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
Study Start Date : April 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
Drug: Dexamethasone
8mg (2mL) of Dexamethasone added to standard LIA mixture
Other Name: Baycadron

Drug: LIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine

Sham Comparator: Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
Other: 0.9% NaCl Placebo
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
Other Name: Saline

Drug: LIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine




Primary Outcome Measures :
  1. Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively [ Time Frame: 3 days - post operative ]

Secondary Outcome Measures :
  1. Analgesic outcomes- pain [ Time Frame: 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


  2. Analgesic outcomes- opiate consumption [ Time Frame: 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. Analgesic outcomes- TUG test [ Time Frame: 3 days - post operative ]
    Timed Up and Go Test (TUG) on postoperative days 2 or 3

  4. Analgesic outcomes- Drug side-effects [ Time Frame: 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

  5. Short-term physical and performance-based functional outcome measures- in hospital complications [ Time Frame: 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

  6. Short-term physical and performance-based functional outcome measures- length of stay [ Time Frame: 3 days - post operative ]
    Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery

  7. Short-term physical and performance-based functional outcome measures- discharge [ Time Frame: 3 days - post operatively ]
    Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre

  8. Medium-term self-reported functional outcome measures- WOMAC [ Time Frame: 3 months- post operative ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively

  9. Medium-term self-reported functional outcome measures- LFES [ Time Frame: 3 months- post operative ]
    Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02760043


Contacts
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Contact: Vincent Chan, MD 4166035118 vincent.chan@uhn.ca
Contact: Kariem El-Boghdadly, MD 4166035800 elboghdadly@gmail.com

Locations
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Canada, Ontario
Toronto Western Hopspital Recruiting
Toronto, Ontario, Canada, M5T2S8
Principal Investigator: Vincent Chan, MD. FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02760043    
Other Study ID Numbers: UHN15-9898-A
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided at this moment.
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents