Postoperative Pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet Western diagnostic criteria for knee osteoarthritis; 2) Age 60-80 years, any gender; 3) BMI 18-34 kg/m²; 4) ASA class I or II, Kellgren-Lawrence (K-L) grade 3 or 4; 5) Knee varus/valgus <15°; 6) First-time right total knee arthroplasty; 7) Right-handed; 8) Normal cognitive function, able to understand instructions and complete the trial.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Patients with severe cardiovascular or cerebrovascular diseases, pacemakers, chronic obstructive pulmonary disease, and neurological disorders such as stroke, brain trauma, epilepsy, severe anxiety, sleep disorders, or mental disorders; 2) Patients with a history of chronic pain, recent use of hormone-based, antipyretic analgesic, or sedative drugs, or those who have received other treatments that may affect the assessment of pain efficacy. Drop-out/Exclusion criteria: 1) Patients with critical postoperative conditions, or changes in condition requiring emergency treatment or transfer to the intensive care unit, or those who experienced adverse reactions during the perioperative period; 2) Patients with poor compliance and those who did not follow the protocol requirements for the trial. Termination/Withdrawal criteria: 1) New diseases that affect the safety evaluation and events considered by the investigator as requiring the termination of the trial; 2) Other (if the subject withdraws from this study voluntarily, the investigator should inquire and record the reason for withdrawal).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Pain Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| EEG Parameters (Power Spectral Density, Functional Connectivity, Brain Network Features, Microstate Analysis);Quality of the patient's recovery period;Postoperative Recovery Quality Self-Assessment Scale;24-Item Hamilton Depression Scale;The recovery status of joint function, such as HSS and WOMAC scores, etc.;postoperative complications; | — |
Countries
China
Contacts
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine