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Clinical study on the efficacy and safety of local application of bupivacaine liposome injection (PBL) combined with compound betamethasone injection (CBI) in reducing perioperative pain in patients undergoing total knee arthroplasty (TKA)

Clinical study on the efficacy and safety of local application of bupivacaine liposome injection (PBL) combined with compound betamethasone injection (CBI) in reducing perioperative pain in patients undergoing total knee arthroplasty (TKA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123920
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Osteoarthritis

Interventions

Experimental Group A:BPL combined with CBI local infiltration and intra-articular injection of CBI. 20ml of BPL (266mg) + 1ml of CBI (dipropyl fluoromethane betamethasone 5mg and betamethasone phospha
Experimental Group B:BPL combined with CBI local infiltration and CBI intra-articular injection. 20ml of BPL (266mg) + 1ml of CBI (dipropyl fluoromethane betamethasone 5mg and betamethasone sodium pho
Experimental Group C:Local infiltration of BPL was performed. 20 ml of BPL (266 mg) was diluted with 60 ml of normal saline to a total volume of 80 ml. It was then injected around the knee joint in th
Control group:Local infiltration with ropivacaine was performed. 20 ml of ropivacaine was mixed with 60 ml of normal saline to dilute it to 80 ml. It was injected around the knee joint according to th

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with primary knee osteoarthritis (OA), with conservative treatment ineffective for more than 6 months, severe joint wear, and Kellgren-Lawrence (KL) grade III–IV. 2.Scheduled to undergo primary unilateral total knee arthroplasty (TKA). 3.Age ranged from 18 to 80 years. 4.American Society of Anesthesiologists (ASA) physical status grade I–III. 5.Voluntarily participated in this study and provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.History of adrenal insufficiency, adrenal injury, or adrenal surgery. 2.Cardiac insufficiency (heart failure), cardiac arrhythmia, or history of cardiac surgery. 3.History of hypersensitivity to BPL or CBI. 4.Presence of local infection focus, non-healed infection focus, or skin lesion at any body site. 5.Use of glucocorticoids within the past 3 months, or history of joint puncture or intra-articular drug injection. 6.Coagulation disorders.

Design outcomes

Primary

MeasureTime frame
VAS score;Morphine and other opioid rescue analgesic doses;Fluctuation levels of the three major inflammatory markers ESR, CRP and IL6 ;

Secondary

MeasureTime frame
Fluctuation of skin temperature around the knee joint;Knee joint range of motion;Postoperative ambulation distance;Fluctuation of blood glucose;HSS score for joint function;WOMAC score for quality of life;Goodman Satisfaction Scale (GSS) ;Length of hospital stay (in hours);Occurrence of postoperative complications (nausea, vomiting, poor wound healing, wound infection, falls, nerve injury, DVT, quadriceps weakness, etc.);

Countries

China

Contacts

Public ContactZeng Yi

West China Hospital, Sichuan University

zengyigd@126.com+86 189 8060 2289

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026