Status:
RECRUITING
Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
Lead Sponsor:
Dezhou Hospital Qilu Hospital of Shandong University
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 abou...
Detailed Description
Total knee replacement (TKA) has made significant progress in the treatment of chronic intractable joint pain, and now the fastest effective way to treat serious knee diseases is to perform artificial...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06557018
Start Date
June 25 2024
End Date
September 15 2024
Last Update
August 16 2024
Active Locations (1)
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1
Qilu Hospital of Shandong University Dezhou Hospital (Dezhou People's Hospital)
Dezhou, Shandong, China, 250012