The efficacy and safety of triamcinolone at different doses on local infiltration anaesthesia in robot-assisted total knee arthroplasty: study protocol for a randomised controlled trial

The efficacy and safety of triamcinolone at different doses on local infiltration anaesthesia in robot-assisted total knee arthroplasty: study protocol for a randomised controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The efficacy and safety of triamcinolone at different doses on local infiltration anaesthesia in robot-assisted total knee arthroplasty: study protocol for a randomised controlled trial Yuhang Zheng, Yang Li, Hua Tian This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4705656/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Background: Local infiltration anaesthesia (LIA) is an integral component of perioperative pain management in total knee arthroplasty (TKA) that facilitates early rehabilitation and reduces the incidence of postoperative complications. However, the optimal formulation of LIA, particularly corticosteroid dosage, remains uncertain. This study aims to assess the pain level and inflammatory response to different doses of triamcinolone in LIA for TKA and to examine its relationship with early clinical outcomes. Methods/design: This double-blind, randomised clinical trial will enrol 112 patients diagnosed with knee osteoarthritis undergoing primary robot-assisted TKA and will be conducted at a single centre. Patients meeting the inclusion and exclusion criteria who consent to participate in the study will be randomised in a 1:1:1:1 ratio into four groups receiving different doses of triamcinolone added to LIA during TKA. The primary outcome will be the pain level during rehabilitation and that at rest. Secondary outcomes include early postoperative local and systemic inflammatory responses, early postoperative active and passive range of motion, early postoperative blood glucose levels, Western Ontario and McMaster Universities Osteoarthritis Index at three months post-TKA, and incidence of complications at three months post-TKA. Ethical approval was obtained from the Institutional Review Board of Peking University Third Hospital. Discussion: This study will assess whether increasing the triamcinolone dose in LIA formulation could alleviate pain in patients following TKA. This study will also assess the early postoperative local and systemic inflammatory responses in the four groups of patients and examine their relationships with early clinical outcomes. We aim to elucidate the optimal dosage of corticosteroids in LIA formulation by evaluating various study endpoints. Trial registration: ClinicalTrials.gov identifier NCT05997238. Registered on 17 May 2023. https://clinicaltrials.gov/study/NCT05997238?id=NCT05997238&rank=1 Protocol version：2.1, 6th April 2023 Robot-assisted total knee arthroplasty Local infiltration anesthesia Corticosteroids Pain Inflammatory response Complication Full Text Supplementary Files completedSPIRITchecklist.pdf Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 25 Jul, 2025 Reviewers invited by journal 24 Jul, 2025 Editor invited by journal 07 Mar, 2025 Editor assigned by journal 27 Dec, 2024 First submitted to journal 10 Sep, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4705656","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":490290958,"identity":"4be64a15-ebfb-41fc-9faa-5ece18cb02ce","order_by":0,"name":"Yuhang Zheng","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8klEQVRIie3RvQrCMBDA8QtCXKJdLyD6Cpn8QMFXEQRdOujmJEqhLrr7Gi7V0VLoFHc3K0InByfBzURdXNKOgvlP5eiPkByAzfaD0dp5Ft4EMgpRDPia9cykDP35BSfNikPiQT5ShaEnmJx0uCfrn1kGoRD6yH1kIpb3pOVG4BRdAY+dgZC5j2NN5GEreBABX14FWUkDKZDPKcdDgJqIoyvU0ECoIiVNTtf0RbqZhBF9fWR8Jun7FMwiSPQjI3Mgbqi7DBnKdBSuDKS2LiZqldOuWmV64UG76iz6m+RhIF8V1CqZ/tjnBADklvtXm81m+6eefJpOwvNDumAAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-5477-9289","institution":"Peking University Third Hospital","correspondingAuthor":true,"prefix":"","firstName":"Yuhang","middleName":"","lastName":"Zheng","suffix":""},{"id":490290959,"identity":"190ce455-b2c6-4220-930f-21d5f6be7deb","order_by":1,"name":"Yang Li","email":"","orcid":"","institution":"Peking University Third Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yang","middleName":"","lastName":"Li","suffix":""},{"id":490290960,"identity":"5d8e121c-5e32-4784-9dd6-1add60684e83","order_by":2,"name":"Hua Tian","email":"","orcid":"https://orcid.org/0000-0001-7139-3372","institution":"Peking University Third Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hua","middleName":"","lastName":"Tian","suffix":""}],"badges":[],"createdAt":"2024-07-08 12:46:38","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4705656/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4705656/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":87765766,"identity":"7538ac17-e411-4474-be1e-26dd12c94b37","added_by":"auto","created_at":"2025-07-28 18:02:11","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":505570,"visible":true,"origin":"","legend":"","description":"","filename":"Manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4705656/v1_covered_a5d6bd81-6814-449c-aeaf-4b5704d2a673.pdf"},{"id":87765478,"identity":"27028e76-da4d-4a14-ae58-87d51a9bbc73","added_by":"auto","created_at":"2025-07-28 17:54:08","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":161780,"visible":true,"origin":"","legend":"","description":"","filename":"completedSPIRITchecklist.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4705656/v1/ecd195356aae53f75b243b68.pdf"}],"financialInterests":"","formattedTitle":"The efficacy and safety of triamcinolone at different doses on local infiltration anaesthesia in robot-assisted total knee arthroplasty: study protocol for a randomised controlled trial","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Robot-assisted total knee arthroplasty, Local infiltration anesthesia, Corticosteroids, Pain, Inflammatory response, Complication","lastPublishedDoi":"10.21203/rs.3.rs-4705656/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4705656/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Local infiltration anaesthesia (LIA) is an integral component of perioperative pain management in total knee arthroplasty (TKA) that facilitates early rehabilitation and reduces the incidence of postoperative complications. However, the optimal formulation of LIA, particularly corticosteroid dosage, remains uncertain. This study aims to assess the pain level and inflammatory response to different doses of triamcinolone in LIA for TKA and to examine its relationship with early clinical outcomes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethods/design: This double-blind, randomised clinical trial will enrol 112 patients diagnosed with knee osteoarthritis undergoing primary robot-assisted TKA and will be conducted at a single centre. Patients meeting the inclusion and exclusion criteria who consent to participate in the study will be randomised in a 1:1:1:1 ratio into four groups receiving different doses of triamcinolone added to LIA during TKA. The primary outcome will be the pain level during rehabilitation and that at rest. Secondary outcomes include early postoperative local and systemic inflammatory responses, early postoperative active and passive range of motion, early postoperative blood glucose levels, Western Ontario and McMaster Universities Osteoarthritis Index at three months post-TKA, and incidence of complications at three months post-TKA. Ethical approval was obtained from the Institutional Review Board of Peking University Third Hospital.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDiscussion: This study will assess whether increasing the triamcinolone dose in LIA formulation could alleviate pain in patients following TKA. This study will also assess the early postoperative local and systemic inflammatory responses in the four groups of patients and examine their relationships with early clinical outcomes. We aim to elucidate the optimal dosage of corticosteroids in LIA formulation by evaluating various study endpoints.\u003c/p\u003e\n\u003cp\u003eTrial registration: ClinicalTrials.gov identifier NCT05997238. 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