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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Perform 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.

Первичные конечные точки

• The incidence rate of the decline in the motor function of the quadriceps femoris muscle [Срок оценки: Before block and 30 minutes after block]
• The success rate of the block [Срок оценки: 30 minutes after block]

Вторичные конечные точки (11)

• Numerical Rating Scale scores during resting/movement [Срок оценки: At 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after surgery]
• Consumption of opioid drugs [Срок оценки: within 48 hours after surgery]
• Duration of analgesia [Срок оценки: within 48 hours after surgery]
• The time of the first out-of-bed activity [Срок оценки: within 48 hours after surgery]
• Patient satisfaction [Срок оценки: within 48 hours after surgery]
• Satisfaction with postoperative rehabilitation [Срок оценки: before discharge]
• The decline range of the quadriceps femoris muscle strength [Срок оценки: 30 minutes after block]
• Toxic reactions of local anesthetics (such as tinnitus, convulsions) [Срок оценки: 7 days after surgery]
• Neurological complications(numbness, tingling pain, muscle weakness) [Срок оценки: within 30 minutes after the completion of the block]
• Whether it affects the sciatic nerve [Срок оценки: within 48 hours after surgery]
• Incidence of Falls [Срок оценки: 7 days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing First Hospital — Нанкин

Публикации

• Chen CM, Yun AG, Fan T. Continuous Bupivacaine Infusion versus Liposomal Bupivacaine in Adductor Canal Block for Total Knee Arthroplasty. J Knee Surg. 2022 Sep;35(11):1268-1272. doi: 10.1055/s-0040-1722661. Epub 2021 Feb 15. PMID 33588474
• Wang C, Zhang Z, Ma W, Li H, du X. Locating Adductor Canal and Quantifying the Median Effective Volume of Ropivacaine for Adductor Canal Block by Ultrasound. J Coll Physicians Surg Pak. 2021 Oct;31(10):1143-1147. doi: 10.29271/jcpsp.2021.10.1143. PMID 34601831
• Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b. PMID 23241723
• Abdallah FW, Mejia J, Prasad GA, Moga R, Chahal J, Theodoropulos J, Dwyer T, Brull R. Opioid- and Motor-sparing with Proximal, Mid-, and Distal Locations for Adductor Canal Block in Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial. Anesthesiology. 2019 Sep;131(3):619-629. doi: 10.1097/ALN.0000000000002817. PMID 31246607

Идентификаторы

NCT: NCT06942689 · KY20250327-13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗