Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
NCT ID: NCT02760459
Last Updated: 2016-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexamethasone
The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs.
Dexamethasone
Placebo
The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push.
Normal saline solution
Interventions
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Dexamethasone
Normal saline solution
Eligibility Criteria
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Inclusion Criteria
* Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
* Undergoing elective, primary and unilateral total knee arthroplasty
* American Society of Anesthesiology (ASA) physical status class 1-3
* BMI \< 40 kg/m2
Exclusion Criteria
* History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
* History of previous surgery on the same knee
* History of adverse effects from medications to be used in this study
* Contraindication to spinal anesthesia
* History of psychiatric disorders or cognitive impairment
* Contraindication to corticosteroid agents
* Poorly controlled diabetes mellitus (HbA1C \> 7.5)
* Poorly controlled hypertension
* History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease
* Hepatic insufficiency (Child-Pugh score \> 5)
* Renal insufficiency (Creatinine clearance \< 30 mL/min)
* History of cataracts or glaucoma or ocular hypertension
* History of steroid or immunosuppressive drug use within 6 months of surgery
40 Years
ALL
No
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Nitchanant Kitcharanant
MD
Principal Investigators
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Nitchanant Kitcharanant, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopedics, Faculty of Medicine, Chiang Mai University
Locations
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Department of Orthopedics, Chiang Mai University
Chiang Mai, ChiangMai, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58.
Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y.
Other Identifiers
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054/2559
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ORT-2558-03245
Identifier Type: -
Identifier Source: org_study_id
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