Postoperative Pain After Total Knee Arthroplasty
Conditions
Interventions
Intervention Group 1:Liposomal Bupivacaine 266 mg/40 ml (total volume)
Intervention Group 3:Liposomal Bupivacaine 266 mg/60 ml (total volume)
Intervention Group 2:Liposomal Bupivacaine 266 mg/60 ml (total volume)
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily signs the informed consent form; 2. Scheduled to undergo unilateral total knee arthroplasty (TKA) under general anesthesia for primary knee osteoarthritis; 3. Aged >=18 years, regardless of gender; 4. American Society of Anesthesiologists (ASA) physical status classification of I to III.
Exclusion criteria
Exclusion criteria: 1. Comorbid psychiatric disorders (e.g., schizophrenia, depression) or sensory disorders (e.g., hyperalgesia); 2. Presence of other severe underlying diseases (e.g., cardiovascular or cerebrovascular diseases) during the screening period that, in the investigator's judgment, render the patient unsuitable to tolerate the surgery; 3. Known allergy, hypersensitivity, or contraindication to bupivacaine, ropivacaine, other amide-type local anesthetics, or any other drugs that may be used during the trial, such as propofol, remimazolam, opioids, dexamethasone, etc. 4. History of drug abuse, illicit drug use, and/or alcohol abuse within 1 year prior to randomization; 5. Female subjects who are pregnant or lactating; 6. Participation in any other clinical trial as a subject within 3 months prior to randomization and/or previous participation in a clinical trial involving the investigational drug or device of this study; 7. Patients with rheumatoid arthritis; 8. Body Mass Index (BMI) >35 kg/m²; 9. Subjects whom the investigator considers to have any other factors that make them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain intensity assessed using the Visual Analog Scale (VAS) during activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Sleep Quality Scale (Athens Insomnia Scale);Postoperative pain intensity assessed using the Visual Analog Scale (VAS) at rest.; | — |
Countries
China
Contacts
Public ContactZhihong Xu
Drum Tower Hospital
Outcome results
None listed