Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty

Recruiting now · Phase 4

Conditions studied: Osteoarthritis, Knee

In brief

The goal of this clinical trial is to learn if drug Bupivacaine liposomes works better than traditional peri-articular injection for Control of Pain in Total Knee Arthroplasty. It will also learn about the safety of drug Bupivacaine liposomes. The main questions it aims to answer are: Does Bupivacaine liposomes works better than traditional peri-articular injection for Control of Pain in Total Knee Arthroplasty. Researchers will compare Bupivacaine liposomes to traditional peri-articular injection to see if drug Bupivacaine liposomes works better for Control of Pain in Total Knee Arthroplasty Participants will: Receive peri-articular injection in total Knee Arthroplasty. checkups and tests During hospitalization.

Key facts

Study ID

NCT06557018

Run by

Dezhou Hospital Qilu Hospital of Shandong University

People needed

60

Starts

2024-06-25

Expected to finish

2024-09-15

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥ 18 years.
• American Society of Anesthesiologists (ASA) classification of grade I-II, with a certain level of literacy, good comprehension of Chinese language and text, no obstacles in doctor-patient communication, good understanding of visual analog scoring of pain (VAS scoring), and the ability to actively cooperate with the relevant examinations
• Proposed initial unilateral total knee arthroplasty (TKA) under general anesthesia without any previous history of knee surgery.
• The patients will participate in the study voluntarily, sign an informed consent form, and cooperate with all the assessments.

You may not qualify if…

• Patients with other pain management options prior to surgery
• Patients with neuromuscular pathology in the operated limb with other comorbidities that may affect postoperative recovery
• Patients with allergy, hypersensitivity, intolerance, or contraindication to any of the drugs on study
• Patients with a history of coronary artery, vascular stent placement, deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke treated within the past 6 months
• The existence of serious liver and kidney dysfunction, coagulation disorders, cardiac arrhythmia, infection and other contraindications to surgery；
• patients with any neurological or psychiatric disorders that may affect postoperative pain or interfere with study evaluation；
• Patients with a history of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.

Where it is running

• Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital) — Dezhou, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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