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Effect of Preoperative Steroid in Total Knee Arthroplasty

Primary Purpose

Arthropathy of Knee

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate
Saline Solution
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Any patient scheduled for primary total knee replacement arthroplasty

Exclusion Criteria:

  1. Diabetic patients
  2. Rheumatoid arthritis patients
  3. Patients on regular steroid therapy
  4. Patients refused to be enrolled in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Dexamethasone group

    Placebo group

    Arm Description

    this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision

    this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision

    Outcomes

    Primary Outcome Measures

    Postoperative pain summarized in the first 14 days
    postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm.

    Secondary Outcome Measures

    Postoperative Thigh circumference in the first 14 days
    Postoperative oedema will be assessed for all participants by measuring Thigh circumference 1 cm above the upper pole of the patella postoperatively at day 1,2,3 and 14
    postoperative nausea and vomiting in the first 14 days
    postoperative nausea and vomiting summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery Nausea and vomiting is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no nausea nor vomiting and 100 is the worst nausea and vomiting one can imagine Moderate pain is considered a VAS >30 mm.
    postoperative knee flexion in the first 14 days
    Knee flexion assessed over first 14 days after surgery assessed by knee range of motion measured by goniometer where straight knee joint measure 0 degree.
    Surgical wound infection in the first 14 days
    wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively

    Full Information

    First Posted
    September 5, 2019
    Last Updated
    December 19, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04084912
    Brief Title
    Effect of Preoperative Steroid in Total Knee Arthroplasty
    Official Title
    The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative: pain oedema nausea and vomiting quadriceps power knee flexion wound complications
    Detailed Description
    Total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. Many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and C-reactive protein may be elevated.Furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . The inflammatory response after TKA is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . Inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. Steroids may be associated with decreased levels of interleukin-6 and C reactive protein and may, thus, relieve the pain associated with surgery. Dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase A, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . In addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids[5] . Some studies also reported potential adverse events, such as infection .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthropathy of Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone group
    Arm Type
    Active Comparator
    Arm Description
    this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone Sodium Phosphate
    Other Intervention Name(s)
    Steroid
    Intervention Description
    intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Saline Solution
    Other Intervention Name(s)
    saline
    Intervention Description
    intravenous injection of one ampoule saline
    Primary Outcome Measure Information:
    Title
    Postoperative pain summarized in the first 14 days
    Description
    postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Postoperative Thigh circumference in the first 14 days
    Description
    Postoperative oedema will be assessed for all participants by measuring Thigh circumference 1 cm above the upper pole of the patella postoperatively at day 1,2,3 and 14
    Time Frame
    14 days
    Title
    postoperative nausea and vomiting in the first 14 days
    Description
    postoperative nausea and vomiting summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery Nausea and vomiting is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no nausea nor vomiting and 100 is the worst nausea and vomiting one can imagine Moderate pain is considered a VAS >30 mm.
    Time Frame
    14 days
    Title
    postoperative knee flexion in the first 14 days
    Description
    Knee flexion assessed over first 14 days after surgery assessed by knee range of motion measured by goniometer where straight knee joint measure 0 degree.
    Time Frame
    14 days
    Title
    Surgical wound infection in the first 14 days
    Description
    wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any patient scheduled for primary total knee replacement arthroplasty Exclusion Criteria: Diabetic patients Rheumatoid arthritis patients Patients on regular steroid therapy Patients refused to be enrolled in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Nady, physician
    Phone
    +2001203649367
    Email
    david011183@med.au.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohammed abdelnasser, Doctor
    Phone
    +2001002438664
    Email
    abdelnasser.m.k@med.au.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hatem Bakr, asst. prof
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28614237
    Citation
    Xing LZ, Li L, Zhang LJ. Can intravenous steroid administration reduce postoperative pain scores following total knee arthroplasty?: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(24):e7134. doi: 10.1097/MD.0000000000007134.
    Results Reference
    background
    PubMed Identifier
    25564196
    Citation
    Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.
    Results Reference
    background
    PubMed Identifier
    29481989
    Citation
    Fan Z, Ma J, Kuang M, Zhang L, Han B, Yang B, Wang Y, Ma X. The efficacy of dexamethasone reducing postoperative pain and emesis after total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:149-155. doi: 10.1016/j.ijsu.2018.02.043. Epub 2018 Feb 23.
    Results Reference
    background
    PubMed Identifier
    28614232
    Citation
    Meng J, Li L. The efficiency and safety of dexamethasone for pain control in total joint arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jun;96(24):e7126. doi: 10.1097/MD.0000000000007126.
    Results Reference
    background
    PubMed Identifier
    28655354
    Citation
    Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.
    Results Reference
    background

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    Effect of Preoperative Steroid in Total Knee Arthroplasty

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