Clinical trial NCT06942689: Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Optimal Volume of Liposomal Bupivacaine
Keywords: Liposomal Bupivacaine
Adductor Canal Block
Knee Surgery
Maximum Tolerated Volume
Quadriceps Muscle Strength
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: The incidence rate of the decline in the motor function of the quadriceps femoris muscle
timeFrame: Before block and 30 minutes after block
measure: The success rate of the block
timeFrame: 30 minutes after block
Secondary outcomes:
measure: Numerical Rating Scale scores during resting/movement
timeFrame: At 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after surgery
measure: Consumption of opioid drugs
timeFrame: within 48 hours after surgery
measure: Duration of analgesia
timeFrame: within 48 hours after surgery
measure: The time of the first out-of-bed activity
timeFrame: within 48 hours after surgery
measure: Range of motion (ROM) of the knee joint
timeFrame: within 48 hours after surgery
measure: Patient satisfaction
timeFrame: within 48 hours after surgery
measure: Satisfaction with postoperative rehabilitation
timeFrame: before discharge
measure: The decline range of the quadriceps femoris muscle strength
timeFrame: 30 minutes after block
measure: Toxic reactions of local anesthetics (such as tinnitus, convulsions)
timeFrame: 7 days after surgery
measure: Neurological complications(numbness, tingling pain, muscle weakness)
timeFrame: within 30 minutes after the completion of the block
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Hongwei Shi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.