Osteoarthritis of the knee
Conditions
Interventions
A:The patients received local infiltration anesthesia with a traditional mixture of ropivacaine (including 200mg of ropivacaine, 0.2mg of epinephrine, and 10mg of dexamethasone, totaling 100ml) during
B:The patients used a liposome solution of bupivacaine (containing 266mg of bupivacaine in a total of 100ml) for local infiltration analgesia during surgery.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients with severe osteoarthritis of the knee requiring initial unilateral TKA; (2) Aged between 18 and 80; (3) Preoperative American Society of Anesthesiologists (ASA) physical status classification (anesthesia risk assessment) of I to III.
Exclusion criteria
Exclusion criteria: (1) Patients with failure of vital organs such as heart, lung, etc; (2) Patients with abnormal liver and kidney function (ALT, AST>1.5 times of normal value, BUN>-8.3 mmoll, Scr>115 umol/L); (3) Diabetic patients with poorly controlled blood sugar levels, judged by the investigator to have an infection risk; (4) Patients with consciousness disorder or mental illness; (5) Patients with a history of open knee surgery; (6) Patients with neuro-muscular function disorders affecting lower limb function; (7) Patients with severe impairment of coagulation function; (8) Patients with severe internal or external diseases or weak physique, unable to tolerate surgery; (9) Patients with severe instability and TKA using ligament retention cannot be cured; (10) Patients with active infection foci (systemic or local infection lesions); (11) Patients with severe osteoporosis, metabolic bone disease, radiation-induced bone disease, or tumors around the knee joint; (12) Female subjects who are pregnant, lactating, or on the contraceptive during the entire clinical study period; (13) Subjects who have participated in other clinical trials within 3 months; (14) Subjects who are deemed unsuitable for participation in this clinical trial by the investigator for other reasons; (15) Knee flexion deformity =30° or varus or valgus deformity =30°; (16) Subjects who are allergic to the drugs used in this study; (17) Subjects with addiction to opioids; (18) Subjects with language barriers and unable to complete the pain numerical rating scale (Visual analogue scale, VAS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative dosage of remedial morphine hydrochloride;Time to first postoperative remedial analgesia;VAS pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Range of knee motion;Daily walking distance;The duration of hospital stay;Incidence of postoperative complications; | — |
Countries
China
Contacts
Public ContactJing Yang; Pengde Kang
West China Hospital, Sichuan University
Outcome results
None listed