Optimal Volume of Liposomal BupivacainePhase 4NCT06942689
Determination of the Optimal Volume of Liposomal Bupivacaine in Adductor Canal Block for Knee Joint Surgery
A Phase 4 study testing Perform adductor canal block with liposomal bupivacaine. in people with Optimal Volume of Liposomal Bupivacaine, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Optimal Volume of Liposomal Bupivacaine
- What is being tested?
- Perform adductor canal block with liposomal bupivacaine.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Jie Wei, 18752113232, 961683175@qq.com
About this study
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
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.
- Conditions
- Optimal Volume of Liposomal Bupivacaine
- Being tested
- Perform adductor canal block with liposomal bupivacaine.
- Keywords
- Liposomal Bupivacaine, Adductor Canal Block, Knee Surgery, Maximum Tolerated Volume, Quadriceps Muscle Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perform adductor canal block with liposomal bupivacaine.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block | Experimental | Phase I: The Bayesian Optimal Interval (BOIN) design is adopted to evaluate the volume escalation of liposomal bupivacaine (5, 10, 15, 20, 25, 30, 35, 40 mL). There are 3 cases in each group, with an initial volume of 20 mL (referring to previous ACB studies d). The target incidence of adverse events (quadriceps femoris muscle strength decline ≥ 25%) is set at 10%, and the maximum volume is limited to 40 mL to avoid local anesthetic toxicity.
Phase II: Cohort expansion is carried out at volume levels lower than the MTV. The Bayesian Optimal Phase II (BOP2) design is adopted, with each group expanded to 12 cases to evaluate the balance point between block success rate and motor function preservation. Receives: Drug: Perform adductor canal block with liposomal bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of the decline in the motor function of the quadriceps femoris muscle
The maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle is measured using a handheld dynamometer (HHD) and then re - measured 30 minutes after the block. A decrease in muscle strength of ≥ 25% is defined as a significant impact on motor function.
Measured: Before block and 30 minutes after block
The success rate of the block
Sensory block at 30 minutes after surgery (pinprick test at several sites in the area innervated by the saphenous nerve) and a resting NRS score ≤ 3 points. The sensory block is evaluated using a pinprick test for sensation. This test is performed before the adductor canal block (baseline) and every 5 minutes after the nerve block until 30 minutes have elapsed or the surgery begins. The sensory test is carried out in the distribution area of the saphenous nerve (medial side of the lower leg), as well as on the anterior, medial, lateral, and posteromedial sides of the surgical knee joint, and above the patella. A sensory score of 2 indicates normal sensation, 1 indicates hypoesthesia, and 0 indicates no sensation. We define a successful adductor canal block as the occurrence of sensory block in the surgical knee joint within 30 minutes after the nerve block, that is, the loss of sensation to the pinprick (sensory score of 1 or lower).
Measured: 30 minutes after block
Secondary outcomes (12)
Numerical Rating Scale scores during resting/movement
The NRS (Numeric Rating Scale) scores range from 0 to 10 in total. A score of 0 represents no pain, while a score of 10 indicates severe pain. A score of 0 to 3 indicates mild pain, which is tolerable and does not affect sleep. A score of 4 to 6 indicates moderate pain, which is more obvious and will somewhat interfere with the patient's daily life and sleep, but is still bearable. A score of 7 to 10 indicates severe pain, which is intense and difficult to endure, seriously affecting the patient's daily life and sleep. The lower the score, the better the analgesic effect of the adductor canal block performed with liposomal bupivacaine.
Measured: At 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72hours after surgery
Consumption of opioid drugs
converted into morphine equivalent, mg. After performing the adductor canal block with liposomal bupivacaine, the lower the consumption of opioid drugs, the better the effect of nerve block and the more prolonged the blocking duration.
Measured: within 72 hours after surgery
Duration of analgesia
The time from the completion of the block to the first need for rescue analgesia.
Measured: within 72 hours after surgery
The time of the first out-of-bed activity
Observe the impact of adductor canal block on the patient's motor function. If the patient can get out of bed and move for the first time within a relatively short and reasonable period, it usually indicates that the nerve block has a good effect. It can effectively relieve pain without excessively affecting the patient's motor function, enabling the patient to regain a certain degree of activity ability at an earlier stage.
Measured: 7 days after surgery
Patient satisfaction
Total score of 10 points (0 points: extremely dissatisfied, 10 points: extremely satisfied). Higher scores indicate greater patient satisfaction and better efficacy of nerve block.
Measured: 7 days after surgery
Satisfaction with postoperative rehabilitation
The patient's self-evaluated recovery experience (Likert 5-point scale). The Likert five-point scale employs an odd-numbered grading system (5-point scale), with each item corresponding to five options representing an intensity gradient of attitudes or experiences. Common expressions include:
Strongly Disagree / Very Poor (1 point) Disagree / Poor (2 points) Neutral / Average (3 points) Agree / Good (4 points) Strongly Agree / Very Good (5 points) The total score is calculated by summing the scores of all items, reflecting the overall positivity of the evaluated experience (e.g., recovery experience).
Measured: before discharge
The decline range of the quadriceps femoris muscle strength
The percentage change in muscle strength 30 minutes after the block compared to the baseline level.
Measured: 30 minutes after block
Toxic reactions of local anesthetics (such as tinnitus, convulsions)
Pay attention to avoiding blood vessels. Aspirating during drug injection can reduce the toxic reaction of local anesthetics caused by the entry of local anesthetics into the bloodstream.
Measured: within 30 minutes after block
Neurological complications(numbness, tingling pain, muscle weakness)
Observe whether there is nerve injury. Muscle Strength Grading Standards (0-5 Scale) Assessment Method: To assess for neurological complications, inquire whether the patient experiences pain and if numbness is present in the saphenous nerve distribution area.
Assess muscle strength levels through resistance-based grading. Grade 0 : No muscle contraction (complete paralysis) Limbs show no movement or tension.
Grade 1 : Slight muscle contraction without joint movement Muscle twitching visible, no limb motion.
Grade 2: Joint movement possible horizontally but cannot resist gravity Leg slides on bed but cannot lift.
Grade 3 : Can complete motions against gravity but cannot resist external resistance Lifts leg off the bed but collapses under light pressure.
Grade 4: Can resist partial external force but weaker than normal Holds position against mild resistance but fatigues quickly.
Grade 5: Normal strength, fully resists resistance.
Measured: 7 days after surgery
Whether it affects the sciatic nerve
Examine whether the sensory and motor function of the sciatic nerve is impaired
Measured: within 72 hours after surgery
Incidence of Falls
he incidence of falls can reflect the impact of nerve block on quadriceps muscle strength; a higher incidence indicates a greater effect on motor function.
Measured: 7 days after surgery
Incidence of rebound pain
This outcome measure was collected from the first enrolled subject but formally added to the registry via protocol amendment in September 2026. Rebound pain was defined as the transition from well-controlled pain (NRS≤3) while the block is working to severe pain (NRS ≥7) within 72 h of block performance.
Measured: within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Optimal Volume of Liposomal BupivacaineStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Shi, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Hongwei Shi, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942689
- Sponsor's protocol ID
- KY20250327-13
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33588474Wang 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.
PubMed 34601831Jaeger 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.
PubMed 23241723Abdallah 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.
PubMed 31246607
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06942689
- Acronym / sponsor ID
- KY20250327-13
- Conditions
- Optimal Volume of Liposomal Bupivacaine
- Keywords
- Liposomal Bupivacaine, Adductor Canal Block, Knee Surgery, Maximum Tolerated Volume, Quadriceps Muscle Strength
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block | Experimental | Drug: Perform adductor canal block with liposomal bupivacaine.Phase I: The Bayesian Optimal Interval (BOIN) design is adopted to evaluate the volume escalation of liposomal bupivacaine (5, 10, 15, 20, 25, 30, 35, 40 mL). There are 3 cases in each group, with an initial volume of 20 mL (referring to previous ACB studies d). The target incidence of adverse events (quadriceps femoris muscle strength decline ≥ 25%) is set at 10%, and the maximum volume is limited to 40 mL to avoid local anesthetic toxicity. Phase II: Cohort expansion is carried out at volume levels lower than the MTV. The Bayesian Optimal Phase II (BOP2) design is adopted, with each group expanded to 12 cases to evaluate the balance point between block success rate and motor function preservation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Femoral neuropathy.
- Coagulation dysfunction.
- Allergy to local anesthetics.
- Infection at the puncture site.
- History of chronic pain or opioid use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. 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. | Drug | Adductor Canal Block |
Primary outcome
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 maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle is measured using a handheld dynamometer (HHD) and then re - measured 30 minutes after the block. A decrease in muscle strength of ≥ 25% is defined as a significant impact on motor function.
The success rate of the block
Time frame: 30 minutes after block
Sensory block at 30 minutes after surgery (pinprick test at several sites in the area innervated by the saphenous nerve) and a resting NRS score ≤ 3 points. The sensory block is evaluated using a pinprick test for sensation. This test is performed before the adductor canal block (baseline) and every 5 minutes after the nerve block until 30 minutes have elapsed or the surgery begins. The sensory test is carried out in the distribution area of the saphenous nerve (medial side of the lower leg), as well as on the anterior, medial, lateral, and posteromedial sides of the surgical knee joint, and above the patella. A sensory score of 2 indicates normal sensation, 1 indicates hypoesthesia, and 0 indicates no sensation. We define a successful adductor canal block as the occurrence of sensory block in the surgical knee joint within 30 minutes after the nerve block, that is, the loss of sensation to the pinprick (sensory score of 1 or lower).
12 secondary outcomes
Numerical Rating Scale scores during resting/movement
Time frame: At 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72hours after surgery
Consumption of opioid drugs
Time frame: within 72 hours after surgery
Duration of analgesia
Time frame: within 72 hours after surgery
The time of the first out-of-bed activity
Time frame: 7 days after surgery
Patient satisfaction
Time frame: 7 days 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: within 30 minutes after block
Neurological complications(numbness, tingling pain, muscle weakness)
Time frame: 7 days after surgery
Whether it affects the sciatic nerve
Time frame: within 72 hours after surgery
Incidence of Falls
Time frame: 7 days after surgery
Incidence of rebound pain
Time frame: within 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 33588474Chen 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.
- Background: PubMed 34601831Wang 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.
- Background: PubMed 23241723Jaeger 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.
- Background: PubMed 31246607Abdallah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongwei Shi principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perform adductor canal block with liposomal bupivacaine. in people with Optimal Volume of Liposomal Bupivacaine, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Han (18951670163, han_cold.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06942689, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.