---
title: Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty
nct_id: NCT07442812
overall_status: NOT_YET_RECRUITING
sponsor: Haseki Training and Research Hospital
study_type: OBSERVATIONAL
primary_condition: Knee Osteoarthritis
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07442812.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07442812"
ct_last_update_post_date: 2026-03-04
last_seen_at: "2026-05-12T06:29:44.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty

**Official Title:** The Role of Dexamethasone in Total Knee Arthroplasty: Effects of Oral and Intravenous Administration on Early Postoperative Pain and Mobilization

**NCT ID:** [NCT07442812](https://clinicaltrials.gov/study/NCT07442812)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 99
- **Lead Sponsor:** Haseki Training and Research Hospital
- **Conditions:** Knee Osteoarthritis, Gonarthrosis; Primary, Total Knee Arthroplasty
- **Start Date:** 2026-03-31
- **Completion Date:** 2026-08
- **CT.gov Last Update:** 2026-03-04

## Brief Summary

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.

## Detailed Description

Total knee arthroplasty (TKA) is an effective treatment for advanced knee osteoarthritis; however, early postoperative recovery may be influenced by pain severity, limited functional mobility, systemic inflammatory response, metabolic alterations, and postoperative nausea and vomiting. Optimization of perioperative medical management is therefore a key component of enhanced recovery pathways.

Dexamethasone is frequently incorporated into perioperative care due to its anti-inflammatory, analgesic, antiemetic, and metabolic effects. Despite widespread use, variability persists in routine clinical practice regarding route of administration and dosing strategies. Comparative real-world data evaluating oral and intravenous administration within standardized care pathways remain limited.

This study is designed as a single-center, prospective observational cohort investigation evaluating early postoperative recovery parameters associated with routine perioperative dexamethasone strategies. The study does not introduce experimental interventions, randomization, or alterations to established treatment protocols.

Participants are assigned to cohorts according to the routine perioperative management approach of the operating surgeon selected by the patient. Each participating surgeon follows a predefined dexamethasone protocol that was implemented prior to initiation of this study. Treatment allocation is therefore independent of the research process and reflects real-world clinical practice.

The exposure of interest is perioperative dexamethasone administration as part of routine clinical care. Exposure status is defined according to the route of administration applied within the surgeon's established perioperative protocol: intravenous dexamethasone, oral dexamethasone, or no dexamethasone.

The standard institutional regimens consist of 8 mg administered preoperatively and 4 mg administered on postoperative day one, delivered either intravenously or orally depending on routine practice. Patients receiving no dexamethasone serve as the comparison cohort. Exposure classification is determined prior to postoperative outcome assessment.

All surgical procedures are performed using standardized institutional techniques for primary total knee arthroplasty. Postoperative management follows a multimodal analgesic protocol consistent across cohorts. Rescue opioid administration is provided when clinically indicated, and cumulative tramadol dose is recorded. Laboratory monitoring and clinical assessments are performed according to routine perioperative care standards.

Outcome data are collected prospectively using standardized and validated measurement tools during the early postoperative period. Baseline demographic and clinical variables are documented to account for potential confounding factors. Statistical analyses will include appropriate parametric or non-parametric tests depending on distributional assumptions. Repeated measurements will be evaluated using repeated-measures analysis or mixed-effects modeling, with multivariable adjustment to account for baseline differences between cohorts. Statistical significance is defined as p \< 0.05.

The study is conducted in accordance with the Declaration of Helsinki and has received institutional ethics committee approval. All participants provide written informed consent prior to enrollment. Participation does not alter standard clinical management.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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
* Ability to ambulate independently (with or without assistive devices) preoperatively
* Ability to understand study procedures and complete pain and functional assessments
* Provision of written informed consent

Exclusion Criteria:

* Revision total knee arthroplasty
* History of knee joint infection
* Inflammatory arthritis (e.g., rheumatoid arthritis)
* Chronic systemic corticosteroid use
* Uncontrolled diabetes mellitus
* Known endocrine disorders affecting glucose metabolism
* Active infection at any site
* Known hypersensitivity to corticosteroids
* Severe hepatic, renal, or cardiac disease
* Neurological or musculoskeletal disorders affecting gait or balance
* Inability or unwillingness to comply with study procedures
```

## Arms

- **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).
- **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).
- **Control Group (No Dexamethasone)** — Patients undergoing primary total knee arthroplasty who do not receive dexamethasone as part of the routine perioperative management.

## 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.

## Primary Outcomes

- **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.)_ — 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.
- **Functional Mobility (Timed Up and Go Test)** _(time frame: Preoperatively and daily during the first 2 postoperative days.)_ — 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.
- **Nausea and Vomiting (PONV) Score** _(time frame: Assessed daily during the first 2 postoperative days.)_ — 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.
- **Postoperative Opioid Requirement** _(time frame: During the first 48 hours after surgery.)_ — 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.

## Secondary Outcomes

- **White Blood Cell Count** _(time frame: Preoperatively and daily during the first 2 postoperative days.)_
- **C-Reactive Protein Level** _(time frame: Preoperatively and daily during the first 2 postoperative days.)_
- **Postoperative Glycemic Response** _(time frame: Preoperatively and daily during the first 2 postoperative days.)_
- **Knee Range of Motion - Flexion and Extension Angles** _(time frame: Preoperatively and daily during the first 2 postoperative days.)_
- **Postoperative Mobilization Status** _(time frame: Postoperative Day 0, Day 1, and Day 2)_

## Locations (1)

- Sultangazi Haseki Training and Research Hospital, Istanbul, Istanbul, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sultangazi haseki training and research hospital|istanbul|istanbul|turkey (türkiye)` — added _(2026-05-12)_

---

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