Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Routine perioperative management
  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 treatm

Первичные конечные точки

• Postoperative Pain Intensity Measured with Visiual Analog Scale (VAS) [Срок оценки: Measuring once in the preoperative period and every 6 hours during the first 48 hours after surgery.]
• Functional Mobility (Timed Up and Go Test) [Срок оценки: Preoperatively and daily during the first 2 postoperative days.]
• Nausea and Vomiting (PONV) Score [Срок оценки: Assessed daily during the first 2 postoperative days.]
• Postoperative Opioid Requirement [Срок оценки: During the first 48 hours after surgery.]

Вторичные конечные точки (5)

• White Blood Cell Count [Срок оценки: Preoperatively and daily during the first 2 postoperative days.]
• C-Reactive Protein Level [Срок оценки: Preoperatively and daily during the first 2 postoperative days.]
• Postoperative Glycemic Response [Срок оценки: Preoperatively and daily during the first 2 postoperative days.]
• Knee Range of Motion - Flexion and Extension Angles [Срок оценки: Preoperatively and daily during the first 2 postoperative days.]
• Postoperative Mobilization Status [Срок оценки: Postoperative Day 0, Day 1, and Day 2]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Sultangazi Haseki Training and Research Hospital — Istanbul

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07442812 · 194-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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