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Recruiting NCT06942689

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

Phase IV Interventional Optimal Volume of Liposomal Bupivacaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perform adductor canal block with liposomal bupivacaine..
Who it may be relevant to
Registry conditions: Optimal Volume of Liposomal Bupivacaine. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • The incidence rate of the decline in the motor function of the quadriceps femoris muscle [Time frame: Before block and 30 minutes after block]
  • The success rate of the block [Time frame: 30 minutes after block]
Secondary outcome measures (11)
  • Numerical Rating Scale scores during resting/movement [Time frame: At 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after surgery]
  • Consumption of opioid drugs [Time frame: within 48 hours after surgery]
  • Duration of analgesia [Time frame: within 48 hours after surgery]
  • The time of the first out-of-bed activity [Time frame: within 48 hours after surgery]
  • Patient satisfaction [Time frame: within 48 hours after surgery]
  • Satisfaction with postoperative rehabilitation [Time frame: before discharge]
  • The decline range of the quadriceps femoris muscle strength [Time frame: 30 minutes after block]
  • Toxic reactions of local anesthetics (such as tinnitus, convulsions) [Time frame: 7 days after surgery]
  • Neurological complications(numbness, tingling pain, muscle weakness) [Time frame: within 30 minutes after the completion of the block]
  • Whether it affects the sciatic nerve [Time frame: within 48 hours after surgery]
  • Incidence of Falls [Time frame: 7 days after 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing First Hospital — Nanjing

Publications

  • 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

Identifiers

NCT: NCT06942689 · KY20250327-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗