Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block
The Compare the Effect of Peroperative Intravenous Single Dose Dexamethasone and the Addition of Dexamethasone to Femoral Nerve Block on Postoperative Analgesic Consumption Anf Patient Comfort in Unilateral Total Knee Arthroplasty Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Mar 2014
Shorter than P25 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
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 21, 2014
March 1, 2014
3 months
March 17, 2014
March 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analog scale
postoperative 2 day
Secondary Outcomes (1)
analgesic consumption
postoperative 2 day
Study Arms (3)
iv dexamethasone
ACTIVE COMPARATORperioperative 2ml 8 mg ıv dexamethasone
femoral dexamethasone
ACTIVE COMPARATORfemoral block was performed postoperative 30 ml 0,5 % bupivacaine added 2 ml 8 mg dexamethasone
serum physiologic
PLACEBO COMPARATORInterventions
2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain
Eligibility Criteria
You may qualify if:
- between 18-65 age
- knee arthroplasty
- no known allergies to drugs
- ASA 1-2 patients
You may not qualify if:
- history of diabetes
- history of chronic pain treatment
- pregnancy
- severe bronchopulmonary disease
- systemic opioid and steroid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes Univercity Hospital
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ahmet öner, recident
erciyes univercity
- STUDY DIRECTOR
gülen güler, prof
erciyes univercity
Central Study Contacts
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
- resident
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 18, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
March 21, 2014
Record last verified: 2014-03