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Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty (TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102815
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Supakit Kanitnate, Thammasat University

Brief Summary:
To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Normal saline Phase 4

Detailed Description:
Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
Actual Study Start Date : May 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone
Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes
Drug: Dexamethasone
Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes

Placebo Comparator: Placebo
Preoperative intravenous normal saline 50 mL slowly push over 5 minutes
Drug: Normal saline
NSS 50 mL IV slowly push over 5 minutes




Primary Outcome Measures :
  1. post-operative pain [ Time Frame: 48 hours ]
    measured with VAS for pain, drugs for relief pain


Secondary Outcome Measures :
  1. Functional knee score [ Time Frame: 3 month ]
    measured with WOMAC, KSS

  2. post-operative nausea and vomiting [ Time Frame: 48 hours ]
    measured with amount of nausea/vomiting and drugs requiring for fixed its.

  3. complication of preoperative dexamethasone [ Time Frame: 2 weeks ]
    measured with wound complication, blood sugar level

  4. inflammatory level [ Time Frame: 48 hours ]
    CRP level


Other Outcome Measures:
  1. Knee range of motion [ Time Frame: 3 months ]
    measuring range of motion with goniometer



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
  • 50-85 years old
  • ASA class 1-3

Exclusion Criteria:

  • Unable to perform spinal anaesthesia
  • History of drug allergies: steroids
  • Renal impairment (CrCl <30 mL/min)
  • Liver impairment
  • Cognitive function disorders
  • Poor controlled DM (HA1C > 7.5)
  • Morning DTX at operative day > 180 mg%
  • Received corticosteroids within 3 months before surgery

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): NCT02102815


Locations
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Thailand
Orthopaedic department, Faculty of medicine, Thammasat university
Klongluang, Pathumthani, Thailand, 066
Sponsors and Collaborators
Thammasat University
Investigators
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Principal Investigator: Supakit Kanitnate, M.D. Orthopaedics department, Thammasat University
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Responsible Party: Supakit Kanitnate, Orthopaedics department, Thammasat University
ClinicalTrials.gov Identifier: NCT02102815    
Other Study ID Numbers: OrthoTU06
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Supakit Kanitnate, Thammasat University:
total knee arthroplasty
pain control
dexamethasone
steroids
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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