NCT06942689 Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery
| NCT ID | NCT06942689 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Optimal Volume of Liposomal Bupivacaine |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
Building on Bayesian design methodologies from volume optimization studies of ropivacaine in shoulder surgery, this study pioneers the application of a seamless dose-finding strategy in knee ACB. Utilizing advanced statistical models (BOIN/BOP2 design), we aim to systematically evaluate the volume-effect relationship of liposomal bupivacaine, providing precise dosing recommendations to advance personalized and optimized analgesic protocols for knee surgery.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing elective general anesthesia for unilateral knee joint surgery. * Patients who provide informed consent. * Aged between 18 and 65 years old, regardless of gender. * American Society of Anesthesiologists (ASA) physical status classification of Ⅰ to Ⅲ * Body mass index (BMI) ≤ 35 kg/m². Exclusion Criteria: * Femoral neuropathy. * Coagulation dysfunction. * Allergy to local anesthetics. * Infection at the puncture site. * History of chronic pain or opioid use. * Pregnancy. * Diabetes mellitus and peripheral neuropathy.