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Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

Primary Purpose

Arthritis Knee, Postoperative Nausea, Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients age 18 and older who will be undergoing joint replacement

Exclusion Criteria:

  • Patients with uncontrolled diabetes ( HbA1C, >7.5%), impaired hepatic function (Child class, >B), impaired renal failure (Glomerular filtration rate <60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm B: Oral Dexamethasone

    Arm A: Placebo

    Arm Description

    Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days

    Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days

    Outcomes

    Primary Outcome Measures

    Postoperative Pain
    Postoperative pain will be collected via visual analog scores
    Postoperative Nausea
    Postoperative Nausea will be collected via visual analog scores
    Opioid Consumption
    Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded
    Antiemetic Consumption
    Episodes of Nausea

    Secondary Outcome Measures

    Postoperative complications
    Incidence of surgical site infection, acute prosthetic joint infection
    Patient-reported outcome scores (PROMS)
    Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Full Information

    First Posted
    June 12, 2020
    Last Updated
    June 12, 2020
    Sponsor
    Henry Ford Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04432259
    Brief Title
    Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
    Official Title
    Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Henry Ford Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.
    Detailed Description
    Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis Knee, Postoperative Nausea, Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm B: Oral Dexamethasone
    Arm Type
    Experimental
    Arm Description
    Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days
    Arm Title
    Arm A: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    4 mg bid for 4 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    oral placebo
    Primary Outcome Measure Information:
    Title
    Postoperative Pain
    Description
    Postoperative pain will be collected via visual analog scores
    Time Frame
    3 weeks following surgery
    Title
    Postoperative Nausea
    Description
    Postoperative Nausea will be collected via visual analog scores
    Time Frame
    3 weeks following surgery
    Title
    Opioid Consumption
    Description
    Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded
    Time Frame
    6 months
    Title
    Antiemetic Consumption
    Time Frame
    6 months
    Title
    Episodes of Nausea
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Postoperative complications
    Description
    Incidence of surgical site infection, acute prosthetic joint infection
    Time Frame
    6 months
    Title
    Patient-reported outcome scores (PROMS)
    Time Frame
    6 months
    Title
    Knee Injury and Osteoarthritis Outcome Score (KOOS)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult patients age 18 and older who will be undergoing joint replacement Exclusion Criteria: Patients with uncontrolled diabetes ( HbA1C, >7.5%), impaired hepatic function (Child class, >B), impaired renal failure (Glomerular filtration rate <60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Shaw, M.D.
    Phone
    414-405-8544
    Email
    jshaw5@hfhs.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jason Davis, M.D.
    Organizational Affiliation
    Henry Ford Health System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

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