Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection for in Total Knee Arthroplasty: a Prospective, Randomized, Controlled Study
Dezhou Hospital Qilu Hospital of Shandong University
60 participants
Jun 25, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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.
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Interventions
liposomal bupivacaine group
traditional peri-articular injection group
Locations(1)
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NCT06557018