NCT06557018 Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty
| NCT ID | NCT06557018 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dezhou Hospital Qilu Hospital of Shandong University |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2024-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-06-25 with a primary completion date of 2024-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. Male or female, age ≥ 18 years. 2. 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 3. Proposed initial unilateral total knee arthroplasty (TKA) under general anesthesia without any previous history of knee surgery. 4. The patients will participate in the study voluntarily, sign an informed consent form, and cooperate with all the assessments. Exclusion Criteria: 1. Patients with other pain management options prior to surgery 2. Patients with neuromuscular pathology in the operated limb with other comorbidities that may affect postoperative recovery 3. Patients with allergy, hypersensitivity, intolerance, or contraindication to any of the drugs on study 4. 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 5. The existence of serious liver and kidney dysfunction, coagulation disorders, cardiac arrhythmia, infection and other contraindications to surgery； 6. patients with any neurological or psychiatric disorders that may affect postoperative pain or interfere with study evaluation； 7. Patients with a history of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.
Contact & Investigator
Peilai Liu
STUDY CHAIR
Dezhou Hospital Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06557018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06557018 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06557018 currently recruiting?
Yes, NCT06557018 is actively recruiting participants. Contact the research team at sdycsk@126.com for enrollment information.
Where is the NCT06557018 trial being conducted?
This trial is being conducted at Dezhou, China.
Who is sponsoring the NCT06557018 clinical trial?
NCT06557018 is sponsored by Dezhou Hospital Qilu Hospital of Shandong University. The principal investigator is Peilai Liu at Dezhou Hospital Qilu Hospital of Shandong University. The trial plans to enroll 60 participants.