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NCT06942689
Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery
Conditions: Optimal Volume of Liposomal Bupivacaine
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Nanjing First Hospital, Nanjing Medical University
Location: Nanjing First Hospital Nanjing Jiangsu
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.
Source: ClinicalTrials.gov (NCT06942689). StuddyBuddy aggregates publicly available trial information.