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RecruitingPhase 4NCT06942689

Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery

Determination of the Optimal Volume of Liposomal Bupivacaine in Single-Shot Adductor Canal Block for Knee Joint Surgery-A Phase I/II Trial

Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

63 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Optimal Volume of Liposomal Bupivacaine

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.
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Interventions

DRUGPerform adductor canal block with liposomal bupivacaine.

Patient Positioning: Supine with the surgical limb slightly flexed and externally rotated. Operator Setup: The operator stands on the surgical side, with the ultrasound machine positioned contralaterally. The anterior thigh is sterilized and draped. Ultrasound Technique: A high-frequency (5-12 MHz) linear ultrasound probe (Sonosite M-Turbo), protected by a 3M Tegaderm dressing, is placed perpendicular to the skin at the midpoint between the femoral trochanter and the superior patellar margin. The probe is maneuvered to visualize the adductor canal structures. Needle Insertion: After local anesthesia at the insertion site, a 22G 80 mm needle is advanced using an in-plane technique until the tip reaches the triangular hypoechoic area lateral to the femoral artery. Following negative aspiration for blood, 1.33% liposomal bupivacaine is injected around the target site.

Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT06942689