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Effect of oxycodone for multimodal preemptive analgesia on pain and enhanced recovery after total knee arthroplasty: a prospective, double-blind, randomized controlled trial

Effect of oxycodone for multimodal preemptive analgesia on pain and enhanced recovery after 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
ChiCTR2100044876
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-05-30
Completion date
Unknown
Last updated
2021-11-02

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:Celecoxib 400mg, pregabalin 150mg and placebo (vitamin C) 100mg were taken orally 2 hours before surgery
group B:Celecoxib 400mg, Preabalin 150mg and Oxycodone hydrochloride sustained-release tablets 10mg were taken orally 2 hours before surgery
group C:Celecoxib 400mg, pregabalin 150mg, and paracetamol 325mg were taken orally 2 hours before surgery

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 renal function (ALT, AST, > 1.5 times normal, blood BUN >-8.3 mmol /L, blood Scr >115 umol/L); 3.Diabetic patients with poor control of blood glucose levels and identified by the investigator as at risk of infection; 4.Combined with consciousness disorder or mental illness; 5.Have a history of open knee surgery; 6.Neuromuscular dysfunction affecting lower limb function; 7.Patients with severe coagulation dysfunction; 8.Combined with severe internal and surgical diseases or weak constitution, unable to tolerate surgery; 9.Severe unstable and ligament-preserved TKA cannot be cured; 10.There are active infection foci (systemic or local infection lesions) in the body; 11.Serious osteoporosis, metabolic bone disease, radioactive bone disease and tumor around the knee joint; 12.Family planning, lactating and pregnant women throughout the clinical study period; 13.Participated in other clinical trials within 3 months; 14.The investigator considers it inappropriate to participate in the clinical trial for other reasons; 15.Knee flexion deformity >= 30 degree or varus deformity >= 30 degree; 16.People who are allergic to the drugs used in this study; 17.Addicts to opiates; 18.People with speech disorders and an inability to complete Visual analogue scale (VAS).

Design outcomes

Primary

MeasureTime frame
Dosage of morphine hydrochloride injection for postoperative salvage;

Secondary

MeasureTime frame
Postoperative VAS pain score;Knee HSS score;Range of knee motion;Daily walking distance;Postoperative inflammatory markers (CRP, IL-6);LOS (length of stay);Incidence of complications;

Countries

China

Contacts

Public ContactKang Pengde

West China Hospital, Sichuan University

kangpengd@163.com+86 18280213153

Outcome results

None listed

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