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Comparison of two multimodal analgesic regimens for total knee arthroplasty: a prospective, randomised, open-label, non-inferiority study

Comparison of two multimodal analgesic regimens for total knee arthroplasty: a prospective, randomised, open-label, non-inferiority study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087851
Enrollment
Unknown
Registered
2024-08-06
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-12

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:Patients received 200 mg celecoxib 2 hours before surgery as prophylactic pain control, and all were given 1 mL of a 100-mL mixture containing 2,000 mg of fentanyl on demand using an intraveno
200 mg of celecoxib, 37.5 mg of tramadol, and 650 mg of acetaminophen every 12 hours for six weeks postoperatively
Group B:From preoperative day 2 until the day before surgery, patients took celecoxib 200 mg twice daily (once after breakfast and once after dinner) for preoperative analgesia. After patients resumed

Sponsors

Honghui Hospital, Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosed with osteoarthritis of the knee through clinical and imaging tests and scheduled to undergo initial total knee replacement; 2) Age = 50 years; 3) have no communication difficulties

Exclusion criteria

Exclusion criteria: 1) Previous open surgery on the same side of the knee; 2) having had an intra-articular knee injection or knee arthroscopy within the last three months; 3) is scheduled to have contralateral TKA surgery or any other surgical procedure during the study; 4) suffering from severe pre-operative comorbidities that could lead to hospitalisation during the study or illnesses that would seriously interfere with study participation; 5) Allergy to sulphonamides; 6) History of peptic ulcer disease or history of bleeding disorders; 7) Impaired hepatic function ((alanine aminotransferase (ALT) or menthionine aminotransferase (AST) >100 IU/L or elevated prothrombin time (International Normalised Ratio (INR)) >1.5), or known cirrhosis or liver transplantation; 8) Severe renal impairment (creatinine clearance less than 30 ml/min), previous renal transplantation or in renal dialysis; 9) History of alcohol or other drug abuse or dependence within 5 years prior to enrolment; 10) History of arrhythmia, heart failure, myocardial infarction or arrhythmia at the time of enrolment; 11) Previous history of uncontrolled hypertension with systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at enrolment; 12) Inability to complete the study questionnaire; 13) Refusal to sign the consent form; 14) Patients who refused to be randomised

Design outcomes

Primary

MeasureTime frame
Morphine consumption;

Secondary

MeasureTime frame
Remedial analgesics;PCA consumption;VAS;brief pain inventory;Western Ontario and McMaster Universities;Knee range of motion;SF-36;

Countries

China

Contacts

Public ContactXu Chao

Honghui Hospital, Xi'an Jiaotong University

383697196@qq.com+86 158 2961 3411

Outcome results

None listed

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