Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
Recruiting · NCT06557018 · Interventional (participants receive a specific treatment) · Lead sponsor: Dezhou Hospital Qilu Hospital of Shandong University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital) - Dezhou, Shandong, China