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Efficacy of tranexamic acid on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial

Efficacy of tranexamic acid on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086985
Enrollment
Unknown
Registered
2024-07-16
Start date
2024-07-23
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee

Interventions

Control group:Periarticular local infiltrating drug composition: 100mL saline containing 0.2% ropivacaine, 2.0 µg/mL epinephrine, 0.1 mg/mL dexamethasone.
Experimental group:Periarticular local infiltrating drug composition: 100mL saline containing 0.2% ropivacaine, 2.0 µg/mL epinephrine, 0.1 mg/mL dexamethasone, 10 mg/mL tranaminic acid.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who require first-time unilateral TKA surgery due to severe osteoarthritis of the knee joint; 2. Age range from 18 to 80 years old; 3. The preoperative American Society of Anesthesiologists (ASA) grading (anesthesia risk assessment) is level I-III.

Exclusion criteria

Exclusion criteria: 1. Patients with important organ failure such as heart and lungs; 2. Abnormal liver and kidney function (ALT and AST>1.5 times normal, blood BUN>-8.3 mmol, blood Scr>115 umol/L); 3. Patients with diabetes whose blood sugar level is poorly controlled and who are judged by the researcher to be at risk of infection; 4. Concomitant consciousness disorders or mental illnesses; 5. Have a history of open knee joint surgery; 6. Neuromuscular dysfunction affecting lower limb function; 7. Patients with severe coagulation disorders; 8. Severe internal or surgical diseases or weak physical condition that cannot tolerate surgery; 9. TKA that is severely unstable and cannot be cured with ligament preservation; 10. There are active infection foci in the body (with systemic or local infection lesions); 11. Severe osteoporosis, metabolic bone disease, radiation bone disease, and tumors around the knee joint; 12. Women during family planning, lactation, and pregnancy throughout the entire clinical study period; 13. Those who have participated in other clinical trials within 3 months; 14. The researcher believes that for other reasons, it is not suitable to participate in this clinical trial; 15. Knee joint flexion deformity>=30 ° or eversion deformity>=30 °; 16. Allergies to medication used in this study; 17. Opioid drug addicts; 18. Language disorders and inability to complete the Visual Analogue Scale (VAS) for pain assessment.

Design outcomes

Primary

MeasureTime frame
Postoperative consumption of morphine hydrochloride as rescue analgesia;Time to first rescue analgesia;VAS pain score;Postoperative blood loss;Complication rates;

Secondary

MeasureTime frame
Lower limb swelling;Knee range of motion;Daily ambulation distance;Time to hospital discharge;

Countries

China

Contacts

Public ContactPengde Kang

West China Hospital, Sichuan University

kangpengd@163.com+86 182 8021 3153

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 15, 2026