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

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