Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty
TKA
1 other identifier
interventional
100
1 country
1
Brief Summary
To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 postoperative-pain
Started May 2014
Typical duration for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJanuary 15, 2019
January 1, 2019
1.8 years
March 31, 2014
January 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative pain
measured with VAS for pain, drugs for relief pain
48 hours
Secondary Outcomes (4)
Functional knee score
3 month
post-operative nausea and vomiting
48 hours
complication of preoperative dexamethasone
2 weeks
inflammatory level
48 hours
Other Outcomes (1)
Knee range of motion
3 months
Study Arms (2)
Dexamethasone
EXPERIMENTALPreoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes
Placebo
PLACEBO COMPARATORPreoperative intravenous normal saline 50 mL slowly push over 5 minutes
Interventions
Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- years old
- ASA class 1-3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopaedic department, Faculty of medicine, Thammasat university
Klongluang, Changwat Pathum Thani, 066, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Supakit Kanitnate, M.D.
Orthopaedics department, Thammasat University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedics department
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 3, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2016
Study Completion
June 1, 2016
Last Updated
January 15, 2019
Record last verified: 2019-01