Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty

Sponsor
Haseki Training and Research Hospital
Study ID
NCT07442812
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Routine perioperative management — OTHER
    This 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.

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Mar 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
270 participants (estimated)

Arms

  • Arm: Intravenous Dexamethasone Group
    Patients undergoing primary total knee arthroplasty who receive dexamethasone intravenously according to the routine perioperative protocol of the operating surgeon (8 mg IV preoperatively and 4 mg IV postoperatively).
  • Arm: Oral Dexamethasone Group
    Patients undergoing primary total knee arthroplasty who receive dexamethasone orally according to the routine perioperative protocol of the operating surgeon (8 mg oral preoperatively and 4 mg oral postoperatively).
  • Arm: Control Group (No Dexamethasone)
    Patients undergoing primary total knee arthroplasty who do not receive dexamethasone as part of the routine perioperative management.

Primary Outcome Measure

Postoperative Pain Intensity Measured with Visiual Analog Scale (VAS) [ Time Frame: Measuring once in the preoperative period and every 6 hours during the first 48 hours after surgery. ]

Central Contacts

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