knee osteoarthritis
Conditions
Interventions
Experimental group1:Liposomal bupivacaine diluted to 60ml (4.4mg/ml) + 60ml (ketorolac tromethamine 0.5mg/ml + dexamethasone 0.08mg/ml)
Experimental group2:60ml normal saline + 60ml (ketorolac tromethamine 0.5mg/ml + dexamethasone 0.08mg/ml)
Experimental group3:Liposomal bupivacaine diluted to 60ml (4.4mg/ml) +60ml normal saline
Control group:Ropivacaine hydrochloride 60 ml (4.4 mg/ml) + 60 ml (ketorolac tromethamine 0.5 mg/ml + dexamethasone 0.08 mg/ml)
Sponsors
Zunyi Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Primary unilateral TKA due to knee osteoarthritis. 2.Age between 18 and 80 years. 3.Patients without contraindications to general anesthesia.
Exclusion criteria
Exclusion criteria: 1.Abnormal Liver Function: Defined as alanine transaminase (ALT) and aspartate transaminase (AST) levels exceeding 1.5 times the normal reference range. 2.Diabetes with Poor Glycemic Control: Considered to have a higher risk of infection by the researchers. 3.History of Knee Joint Surgery. 4.Neuromuscular Dysfunction: Affecting the lower extremities. 5.Severe Coagulopathy. 6.Severe Unstable Knee Joint: Unreconstructable ligament-preserving TKA (i.e., cases where ligament preservation is not feasible due to severe instability). 7.Knee Deformities: Flexion deformity of 30° or varus deformity of 30°. 8.Drug Allergies: Allergic to the drugs used in this study or a history of long-term oral glucocorticoid use. 9.Opioid Dependence. 10.Communication Barriers: Inability to use the Visual Analogue Scale (VAS) to report pain or other communication difficulties. 11.Body Mass Index (BMI) > 40 kg/m². 12. Patients with inflammatory and pain-related factors (e.g., CRP, IL-6, TNF-a, IL-1ß) outside the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of rescue analgesic administration;Total postoperative opioid consumption;Visual Analogue Scale;Drug concentrations in blood and joint drainage fluid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of Stay;Patient-Controlled Analgesia demands;Hospital for Special Surgery Knee Score;Pain Catastrophizing Scale Score;Adverse Event Incidence;C-reactive protein;Interleukin-6;Tumor Necrosis Factor-alpha;Interleukin-1 beta; | — |
Countries
china
Contacts
Public ContactCai Dongfeng
Zunyi Medical University Affiliated Hospital
Outcome results
None listed