osteoarthritis of the knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosed with osteoarthritis of the knee through clinical and imaging tests and scheduled to undergo initial total knee replacement; 2) =50 years of age; 3) No barriers to communication; 4) have a physical status of I-III as assessed by the American Society of Anaesthesiologists; 5) Volunteer to participate in the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) other surgical procedures (e.g., major hip, thoracic, or abdominal surgery) within the past year; 2) Previous open surgery on the same side of the knee; 3) have had an intra-articular knee injection or knee arthroscopy within the last three months; 4) planned contralateral TKA surgery or any other surgical procedure during the study period; 5) have a serious preoperative comorbidity that could result in hospitalisation during the study or an illness that would seriously interfere with study participation; 6) have a history of significant peripheral nerve injury; 7) neurological disease or cognitive impairment (e.g., Alzheimer's disease, dementia) that would interfere with the questionnaire; 8) Allergy to or intolerance of duloxetine, pregabalin or anaesthetic drugs; 9) Long-term use of gabapentin or pregabalin (regular use for more than 3 months); 10) Use of duloxetine or other SNRIs, SSRIs, MAOIs, tricyclic antidepressants; 11) Allergy to sulfonamides; 12) History of peptic ulcer or history of bleeding disorders; 13) Impaired hepatic function ((alanine aminotransferase (ALT) or menthionine aminotransferase (AST) >100 IU/L or elevated prothrombin time (International Normalised Ratio (INR)) >1.5), or known cirrhosis or liver transplantation; 14) Severe renal impairment (creatinine clearance less than 30 ml/min), previous renal transplantation or in renal dialysis; 15) Hamilton Depression Scale score >7; 16) History of alcohol or other drug abuse or dependence within 5 years prior to enrolment; 17) History of arrhythmia, heart failure, myocardial infarction or arrhythmia at the time of enrolment; 18) Hyponatraemia (180 mm Hg or diastolic blood pressure >110 mm Hg at the time of enrolment; 20) History of glaucoma (or elevated intraocular pressure), uncontrolled thyroid disease or uncontrolled seizures; 21) Inability to complete the study questionnaire; 22) Patients who refuse randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| brief pain inventory;Western Ontario and McMaster Universities;CSI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intermittent and Constant Osteoarthritis Pain;Knee range of motion;SF-36;HAMD; | — |
Countries
China
Contacts
Honghui Hospital, Xi'an Jiaotong University