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Efficacy of Nefopam on multimodal analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial

Efficacy of Nefopam on multimodal 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
ChiCTR2200060424
Enrollment
Unknown
Registered
2022-06-01
Start date
2022-05-20
Completion date
Unknown
Last updated
2024-05-13

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

Group A:After surgery, celecoxib 200mg, pregabalin 150mg, and nefopam 40mg were given orally, twice daily
Group B:After surgery, celecoxib 200mg, pregabalin 150mg, and placebo were given orally, twice daily

Sponsors

Department of Orthopaedics Surgery, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients requiring primary unilateral TKA due to severe osteoarthritis of the knee; 2. Aged 18 to 80 years; 3. The American Society of Anesthesiologists (American Society of Anesthesiologists, ASA) classification (anesthesia risk assessment) is I~III level.

Exclusion criteria

Exclusion criteria: 1. Patients with heart, lung and other important organ failure; 2. Abnormal liver and kidney function (ALT and AST> 1.5 times of normal value, blood BUN>-8.3 mmoll, blood Scr>115 umol/L); 3. Patients with diabetes mellitus and poorly controlled blood glucose level who are at risk of infection according to researchers; 4. Combined with consciousness disorder or mental illness; 5. Have a history of open knee surgery; 6. Neuromuscular dysfunction affecting lower extremity function; 7. Patients with severe coagulation disorder; 8. Complicated with serious internal or surgical disease or weak constitution, unable to tolerate surgery; 9. Severe instability that cannot be cured by TKA with ligament preservation; 10. There are active infection foci in the body (systemic or local infectious lesions); 11. Severe osteoporosis, metabolic bone disease, radioactive bone disease and tumor around the knee joint; 12. Family planning, lactation and pregnancy women throughout the clinical study period; 13. Those who have participated in other clinical trials within 3 months; 14. Those who are deemed unsuitable for this clinical trial by the researcher for other reasons; 15. Knee flexion deformity >=30 degrees or internal and external varus deformity >=30 degrees; 16. Patients who are allergic to drugs used in this study; 17. Patients addicted to opioids; 18. Patients with language impairment and inability to complete the Visual analogue scale (VAS).

Design outcomes

Primary

MeasureTime frame
Postoperative morphine consumption;

Secondary

MeasureTime frame
The time to first postoperative remedial analgesia;Postoperative visual analog pain score;Range of knee motion;Daily walking distance;Length of stay;Incidence of complications;

Countries

China

Contacts

Public ContactKang Pengde
kangpengd@163.com+86 18280213153

Outcome results

None listed

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