Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty

NCT07442812 | Not Yet Recruiting

• 1 other identifier: 194-2025
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Gonarthrosis; Primary; Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Intravenous Dexamethasone; Knee Osteoarthritis; Gonarthrosis; Multimodal Analgesia

Outcome Measures

Primary Outcomes (4)

• 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.

  Measuring once in the preoperative period and every 6 hours during the first 48 hours after surgery.

• 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.

  Preoperatively and daily during the first 2 postoperative days.

• 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.

  Assessed daily during the first 2 postoperative days.

• 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.

  During the first 48 hours after surgery.

Secondary Outcomes (5)

• White Blood Cell Count

  Preoperatively and daily during the first 2 postoperative days.

• C-Reactive Protein Level

  Preoperatively and daily during the first 2 postoperative days.

• Postoperative Glycemic Response

  Preoperatively and daily during the first 2 postoperative days.

• Knee Range of Motion - Flexion and Extension Angles

  Preoperatively and daily during the first 2 postoperative days.

• Postoperative Mobilization Status

  Postoperative Day 0, Day 1, and Day 2

Study Arms (3)

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).

Other: Routine perioperative management

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).

Other: Routine perioperative management

Control Group (No Dexamethasone)

Patients undergoing primary total knee arthroplasty who do not receive dexamethasone as part of the routine perioperative management.

Other: 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.

Control Group (No Dexamethasone); Intravenous Dexamethasone Group; Oral Dexamethasone Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Sultangazi Haseki Training and Research Hospital

Istanbul, Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (5)

• Chen J, He Y, Deng T, Li Y, Wang X, Zhao M, Li F, Wang C, Tian H. Effects of Dexamethasone on Nausea, Vomiting, and Inflammatory Indexes After Total Knee Arthroplasty. Orthop Surg. 2025 Oct;17(10):2862-2868. doi: 10.1111/os.70139. Epub 2025 Aug 13.

  PMID: 40803755 BACKGROUND

• De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.

  PMID: 21799397 BACKGROUND

• Liang S, Xing M, Jiang S, Zou W. Effect of Intravenous Dexamethasone on Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. Pain Physician. 2022 Mar;25(2):E169-E183.

  PMID: 35322969 BACKGROUND

• Xu B, Ma J, Huang Q, Huang ZY, Zhang SY, Pei FX. Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2018 May;26(5):1549-1556. doi: 10.1007/s00167-017-4506-x. Epub 2017 May 4.

  PMID: 28474088 BACKGROUND

• Chan TCW, Cheung CW, Wong SSC, Chung AYF, Irwin MG, Chan PK, Fu H, Yan CH, Chiu KY. Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1157-1167. doi: 10.1097/EJA.0000000000001372.

  PMID: 33105245 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mehmet Ersin, Associate Professor

  Sultangazi Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atahan Eryilmaz, Resident Physician

CONTACT

+90 552 609 9055; dratahaneryilmaz@gmail.com

Mehmet Ersin, Associate Professor

CONTACT

+90 507 788 60 54; drmehmetersin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics and Traumatology

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 2, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)