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The efficacy and safety study on treatment of pain after total knee arthroplasty with Imrecoxib Tablets, a randomized, double-blind, controlled trial.

The efficacy and safety study on treatment of pain after total knee arthroplasty with Imrecoxib Tablets, a randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013969
Enrollment
Unknown
Registered
2017-12-15
Start date
2017-12-26
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Total Knee Arthroplasty

Interventions

Test group:Imrecoxib Tablets
control group:Placebo

Sponsors

The second affiliated hospital Zhejaing University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Consent to sign informed consent; 2. The total knee arthroplasty was performed under general anesthesia, and 48h morphine analgesia was needed after surgery; 3. The age of the patient must be in 18-80 years old, male or female; 4. ASA classification must be I or II; 5. Patients with knee osteoarthritis must be treated for the first time with total knee arthroplasty; 6. No cognitive impairment communication difficulties or mental and neurological diseases.

Exclusion criteria

Exclusion criteria: 1. They are known to have been allergic to cox-2 inhibitors, sulfonamide, morphine or administration of anesthetics; 2. Patients treated with total knee arthroplasty; 3. Long-term use of sedative analgesic drugs or the history of chronic pain other than knee joint; 4. Patients with abnormal coagulation function; 5. There are any of the following: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, metastatic carcinoma, and Paget disease; 6. Weight <40kg or BMI is not between 18kg/m2-30kg/m2; 7. Oral administration, intramuscular injection hormone and intramuscular injection of hormone in 1 month before surgery; 8. For the first six hours before surgery, a drug with a cox-2 inhibitor, NSAIDS, and a drug that causes pain loss within 24 hours of surgery; 9. Having a history of alcoholism or history of drug addiction; 10. Severe liver and renal insufficiency; 11. Patients with severe diabetes complications, uncontrollable angina pectoris, uncontrollable arrhythmias, and severe heart failure history; 12. Active esophagus, stomach, pylorus or duodenal ulcer/hemorrhage, or recurrent ulcer/hemorrhagic patients; 13. Active esophagus, stomach, pylorus or duodenal ulcer/hemorrhage, or recurrent ulcer/hemorrhagic patients; 14. Some researchers think it is not appropriate to use experimental drugs.

Design outcomes

Primary

MeasureTime frame
The total amount of tramadol was used in the two groups at 96h after surgery;

Secondary

MeasureTime frame
The VAS score in patients at 6h?24h?48h?96h after surgery;Consumption of tramadol;The overall evaluation of patients for analgesia;Consumption of morphine;The levels of il-1ß, il-6 and il-8 protein markers;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactShigui Yan

The Second Affiliated Hospital Zhejaing University School of Medicine

zrjwsj@zju.edu.cn+86 13906531308

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026