Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorHaseki Training and Research Hospital
About this trial
This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. In routine clinical practice, dexamethasone may be administered orally, intravenously, or not administered, depending on the surgeon's established perioperative protocol.
The primary objective is to assess early postoperative recovery in terms of pain intensity, functional mobility, and knee joint range of motion. Secondary objectives include evaluation of inflammatory response, postoperative metabolic changes, opioid requirement, and the severity of postoperative nausea and vomiting (PONV).
Group allocation is non-randomized and determined solely by the standard perioperative management approach routinely applied by the surgeon selected by the patient. No additional interventions are introduced for research purposes. All outcomes are assessed prospectively during the early postoperative period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 50 and 80 years
Diagnosis of primary knee osteoarthritis (primary gonarthrosis)
Scheduled for elective primary total knee arthroplasty
ASA physical status I or II
Disqualifiers
Revision total knee arthroplasty
History of knee joint infection
Inflammatory arthritis (e.g., rheumatoid arthritis)
Chronic systemic corticosteroid use
Trial population
The study population consists of adult patients aged 50 to 80 years with a diagnosis of primary knee osteoarthritis who are scheduled to undergo elective primary total knee arthroplasty at Istanbul Sultangazi Haseki Training and Research Hospital. Eligible participants have an ASA physical status of I or II and are able to ambulate independently prior to surgery. All participants are capable of understanding the study procedures and providing written informed consent. Patients are managed according to the routine perioperative dexamethasone protocols of the surgeon selected by the patient. Group allocation is based on the standard clinical practice of the chosen surgeon and not assigned by the investigators. Participants are followed prospectively to evaluate postoperative pain, inflammatory response, functional mobility, postoperative nausea and vomiting, and analgesic requirements during the early postoperative period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Routine perioperative management
Other interventionThis is a prospective observational cohort study. No intervention is assigned by the investigators. Patients are managed according to the routine perioperative dexamethasone protocols of the surgeon chosen by the patient. One cohort receives intravenous dexamethasone (8 mg preoperatively and 4 mg postoperatively), one cohort receives oral dexamethasone (8 mg preoperatively and 4 mg postoperatively), and a control cohort receives no dexamethasone. All other perioperative and postoperative treatments are provided according to standard institutional practice and are not influenced by study participation.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Intravenous Dexamethasone Group1 intervention
Group B: Oral Dexamethasone Group1 intervention
Group C: Control Group (No Dexamethasone)1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Intensity Measured with Visiual Analog Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 0 to 10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity and therefore a worse outcome. Pain will be evaluated both at rest and during ambulation.
Time frame
Measuring once in the preoperative period and every 6 hours during the first 48 hours after surgery.2
Functional Mobility (Timed Up and Go Test)
Functional mobility will be evaluated using the Timed Up and Go (TUG) test, which measures the time (in seconds) required for a participant to stand up from a seated position, walk three meters, turn, walk back, and sit down. Shorter completion times indicate better functional mobility, whereas longer times indicate poorer performance.
Time frame
Preoperatively and daily during the first 2 postoperative days.3
Nausea and Vomiting (PONV) Score
Severity of postoperative nausea and vomiting will be assessed using a 0 to 10 Numeric Rating Scale (NRS), where 0 indicates no symptoms and 10 indicates the most severe nausea or vomiting imaginable. Higher scores represent worse symptoms.
Time frame
Assessed daily during the first 2 postoperative days.4
Postoperative Opioid Requirement
Requirement for rescue opioid analgesia following routine postoperative analgesic protocol consisting of scheduled paracetamol (4 doses per day) and NSAIDs (2 doses per day). Total opioid consumption and proportion of patients requiring opioid analgesia will be recorded. Cumulative tramadol dose administered as rescue analgesia will be recorded in milligrams (mg) during the first 48 hours after surgery. Higher values indicate greater postoperative analgesic requirement.
Time frame
During the first 48 hours after surgery.Secondary outcomes
1
White Blood Cell Count
Systemic inflammatory response will be assessed by measuring white blood cell (WBC) count, expressed in ×10³/µL. Higher values indicate greater inflammatory response.
Time frame
Preoperatively and daily during the first 2 postoperative days.2
C-Reactive Protein Level
ystemic inflammatory response will also be assessed by measuring C-reactive protein (CRP) levels, expressed in mg/L. Higher values indicate greater inflammatory response.
Time frame
Preoperatively and daily during the first 2 postoperative days.3
Postoperative Glycemic Response
Serum blood glucose levels will be measured in mg/dL using standard hospital laboratory methods. Daily postoperative values will be recorded to evaluate metabolic response and potential dexamethasone-associated hyperglycemia. Higher values indicate increased glycemic response.
Time frame
Preoperatively and daily during the first 2 postoperative days.4
Knee Range of Motion - Flexion and Extension Angles
Knee range of motion will be measured in degrees (°) using a standard universal goniometer aligned with anatomical landmarks (greater trochanter, lateral femoral epicondyle, and lateral malleolus). Measurements will be performed by trained personnel following a standardized protocol to minimize inter-observer variability. Greater flexion angles indicate improved joint mobility, whereas higher extension deficit values indicate reduced extension capacity.
Time frame
Preoperatively and daily during the first 2 postoperative days.Sponsors and contacts
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Source ClinicalTrials.gov