Analgesic effect of intraosseous parecoxib sodium injection during total knee arthroplasty: a single-center, three-arm, randomized controlled trial
Patients with knee osteoarthritis who require total knee arthroplasty
This study aims to compare the analgesic effects of three different administration routes of parecoxib sodium during total knee arthroplasty (TKA). Except for the specific routes described below, all three groups of participants will receive identical surgical procedures, basic analgesia, rehabilitation protocols, and other perioperative management strategies. The details are as follows: In each group, the drug is 40 mg of injectable parecoxib sodium (Emeishan Tonghui Pharmaceutical Co., Ltd., specification: 20 mg per vial), diluted to 20 ml with 0.9% normal saline. The specific administration protocols are as follows: 1. Intravenous injection group: Before inflation of the lower extremity tourniquet, an anesthesiologist slowly injects the 20 ml parecoxib dilution through an intravenous line, ensuring the drug enters the systemic circulation before the limb circulation is blocked, thereby achieving systemic distribution. 2. Intra‑articular injection group: Before prosthesis implantation, the 20 ml parecoxib dilution is injected with a syringe into multiple pain targets, including the intra‑articular space, posterior capsule, attachment points of the medial and lateral collateral ligaments, the insertion of the quadriceps tendon, and the peri‑articular soft tissues. This allows the drug to remain in the local tissues and exert its analgesic effect while minimizing systemic exposure. 3. Intraosseous injection group: After arthrotomy and full exposure of the proximal tibia, but before the tibial cut, the following steps are performed: in the cancellous bone area approximately 1 cm medial or lateral to the tibial tuberosity, an injection cannula is inserted perpendicularly into the cancellous bone to a depth of about 1.5–2.0 cm. After confirming secure placement, a syringe is connected and the 20 ml parecoxib dilution is slowly injected. Upon needle withdrawal, gentle pressure is applied to the puncture site with bone wax or a gelatin sponge to seal the hole. The drug i
1. Patients aged 50–75 years with a primary diagnosis of knee osteoarthritis 2. Patients scheduled for primary, elective, unilateral total knee arthroplasty without clear contraindications to surgery 3. American Society of Anesthesiologists (ASA) physical status classification I–III 4. Willing to participate in the study and able to provide written informed consent
1. Body mass index (BMI) >35 kg/m² or body weight <50 kg 2. Presence of contraindications to parecoxib sodium, including: 2.1. Allergic reactions 2.2. History of gastrointestinal bleeding caused by NSAIDs 2.3. Inflammatory bowel diseases such as Crohn's disease or ulcerative colitis 2.4. Diagnosed coronary heart disease, lower extremity atherosclerosis, or cerebral atherosclerosis 3. Severe cardiac, hepatic, or renal insufficiency: 3.1. Cardiac function: New York Heart Association (NYHA) class III or IV, or acute myocardial infarction within the past 6 months 3.2. Hepatic function: Child-Pugh class B or C 3.3. Renal function: estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m² 4. Patients with inflammatory arthropathy, such as rheumatoid arthritis or ankylosing spondylitis 5. Local factors that significantly increase surgical complexity, trauma, or operative time (expected operative time >90 minutes), including: prior ipsilateral knee infection, history of complex fracture, previous periarticular osteotomy, massive periarticular bone defect, functional knee stiffness (preoperative maximum range of motion <50°); or severe deformity (varus >20°, valgus >15°, or flexion >20°) 6. Participation in another clinical trial within the past 6 months 7. Any surgical procedure within the past 3 months 8. Presence of cognitive impairment or psychiatric disorder that prevents compliance with study assessments