Comparing liposomal bupivacaine to traditional pain relief in knee surgery

Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection for in Total Knee Arthroplasty: a Prospective, Randomized, Controlled Study

This study is testing whether a new type of pain relief called liposomal bupivacaine works better than standard pain injections for people having knee surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Dezhou Hospital Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Dezhou, Shandong)
• Trial ID: NCT06557018 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of liposomal bupivacaine compared to traditional peri-articular injections for pain control in patients undergoing total knee arthroplasty. Participants will receive either liposomal bupivacaine or a standard pain management injection during their surgery. The study will assess pain relief, patient satisfaction, and recovery outcomes post-surgery. By focusing on a new formulation of bupivacaine, the trial seeks to improve postoperative analgesia and enhance overall recovery experiences for patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for unilateral total knee arthroplasty and can understand and participate in the study.

Not a fit: Patients with prior knee surgeries or those with conditions affecting pain management may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective pain management option for patients undergoing total knee arthroplasty.

How similar studies have performed: While there are studies on traditional pain management techniques, the application of liposomal bupivacaine in knee replacement is novel and has not been previously tested in this context in China.

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.

Where this trial is running

Dezhou, Shandong

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

Study contacts

• Study coordinator: Ke Song

Conditions Osteoarthritis, Knee