TKATKANCT07616102
Effect of Bupivacaine Liposome Injection on Muscle Strength After Total Knee Arthroplasty
A study testing a single-injection adductor canal block and continuous femoral nerve block in people with TKA and Muscle Strength, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
This study employs a randomized controlled trial to investigate whether bupivacaine liposome injection for adductor canal block can effectively improve lower limb muscle strength after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- TKA, Muscle Strength
- What is being tested?
- a single-injection adductor canal block and continuous femoral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 3 Nov 2026
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 60-75 years scheduled for elective TKA;
- ASA physical status classification II-III;
- BMI 18-30 kg/m²;
- Agreement to participate in this study and provision of signed informed consent.
Who cannot join
- Individuals with communication barriers such as language or hearing impairments;
- Patients with contraindications to nerve blocks;
- Severe systemic diseases, such as severe renal disease (estimated glomerular filtration rate below 50 mL/min), cardiac disease (congestive heart failure New York Heart Association Class III to IV), or severe hepatic disease defined as a current or past diagnosis of acute/subacute hepatic necrosis, acute liver failure, chronic liver disease, liver abscess, hepatic coma, or hepatorenal syndrome;
- History of long-term opioid use (defined as daily or nearly daily opioid use within the past 3 months).
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
General hospital of Ningxia medical university
Yinchuan, Ningxia
Xinli Ni, MD, 86-0951-6743252, xinlini6@nyfy.com.cn
About this study
Official title: Effect of Bupivacaine Liposome Adductor Canal Block on Muscle Strength After Total Knee Arthroplasty.
This study employs a randomized controlled trial to investigate whether bupivacaine liposome injection for adductor canal block can effectively improve lower limb muscle strength after total knee arthroplasty.
Read the detailed description
Total knee arthroplasty (TKA) involves significant trauma, and postoperative patients often experience moderate to severe pain, which limits early knee joint functional exercise and affects functional recovery. Peripheral nerve blocks can effectively relieve pain, but while providing adequate analgesia, they may also affect the motor nerves of the lower limbs, increasing the risk of falls when patients begin ambulation. Some studies have found that the incidence of falls in patients using nerve blocks during the early postoperative period, especially during hospitalization, can be as high as 2% . The actual incidence in clinical practice may be even higher. The period of highest risk is when the nerve block effect has not completely subsided and patients begin attempting to ambulate, typically within 24 to 48 hours after surgery. The loss of muscle strength caused by motor nerve blockade is the most direct cause of postoperative falls, primarily due to severe weakness in key stabilizing muscle groups such as the quadriceps.The adductor canal block has clear advantages. However, traditional local anesthetics, represented by ropivacaine or bupivacaine, typically provide effective analgesia for only 12-24 hours after a single injection, making it difficult to fully cover the peak pain period of 48-72 hours postoperatively. Continuous femoral nerve block with ropivacaine can provide prolonged analgesia. When combined with a sciatic nerve block, it can achieve nearly complete analgesia coverage for the knee. Its drawback is its association with quadriceps impairment, which may increase the risk of falls. Continuous adductor canal block also provides prolonged analgesia and has a lesser impact on postoperative muscle strength, but it faces challenges such as catheter placement difficulty and inconvenience for postoperative mobility. In contrast, bupivacaine liposome can provide analgesia for up to 72 hours. If, while offering high-quality analgesia, bupivacaine liposome indeed causes significant weakening of quadriceps strength during the critical first 2-3 days after surgery, the safety and effectiveness of early patient ambulation would be greatly compromised, potentially even increasing the risk of falls. This would contradict the original intent of using the adductor canal block to preserve muscle strength. Conversely, if it is proven to have a lesser impact on muscle strength compared to continuous femoral nerve block, it could become an almost ideal analgesic option.
- Conditions
- TKA, Muscle Strength
- Being tested
- a single-injection adductor canal block, continuous femoral nerve block
- Keywords
- Bupivacaine Liposome, Adductor Canal Block, TKA, Muscle Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a single-injection adductor canal blockProcedure or surgery
An ultrasound-guided adductor canal block is performed via the conventional adductor canal approach. Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal.
continuous femoral nerve blockProcedure or surgery
An ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach. A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| a single-injection adductor canal block | Experimental | An ultrasound-guided adductor canal block is performed via the conventional adductor canal approach. Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal. Receives: Procedure: a single-injection adductor canal block |
| continuous femoral nerve block | Active comparator | An ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach. A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine. Receives: Procedure: continuous femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Strength
The Maximum Voluntary Isometric Contraction (MVIC) test is used to assess quadriceps strength. The tester holds a handheld dynamometer. The patient sits on the bed with legs hanging naturally, and the knee is flexed to 60°. The patient is instructed to slowly exert force to extend the knee forward. As the patient exerts force, the tester applies an equal and opposite counterforce with the dynamometer to maintain the position and angle of the lower leg. The patient sustains maximum effort for 3-5 seconds, and the peak value displayed on the dynamometer is recorded as the result for that trial. Each leg is tested 2-3 times, with a 60-90 second rest between trials to prevent muscle fatigue from affecting the results. The average value is recorded as the final outcome. The unit of measurement is Newtons (N).
Measured: 24 hours after surgery
Secondary outcomes (6)
Quadriceps muscle strength at other time points
The Maximum Voluntary Isometric Contraction (MVIC) test is used to assess quadriceps strength. The tester holds a handheld dynamometer. The patient sits on the bed with legs hanging naturally, and the knee is flexed to 60°. The patient is instructed to slowly exert force to extend the knee forward. As the patient exerts force, the tester applies an equal and opposite counterforce with the dynamometer to maintain the position and angle of the lower leg. The patient sustains maximum effort for 3-5 seconds, and the peak value displayed on the dynamometer is recorded as the result for that trial. Each leg is tested 2-3 times, with a 60-90 second rest between trials to prevent muscle fatigue from affecting the results. The average value is recorded as the final outcome. The unit of measurement is Newtons (N).
Measured: 48 hours after surgery
Numeric Rating Scale (NRS) Score
Using a scale from 0 to 10 to indicate pain intensity, where 0 represents no pain and 10 represents the worst possible pain.
Measured: 24 and 48 hours after surgery
Quadriceps muscle strength grade
Perform a Manual Muscle Test (MMT). The patient is placed in the supine position, with a soft pillow under the knee to provide slight flexion, or sits on the edge of the bed with legs hanging naturally. The examiner stabilizes the patient's thigh with one hand to prevent hip compensation and applies downward resistance with the other hand just above the patient's ankle. Instruct the patient to forcefully extend the knee against the resistance. Observe muscle contraction and joint range of motion, and assess according to the 0-5 grade muscle strength scale.
Measured: 24 and 48 hours after surgery
Knee Joint Range of Motion
Using a goniometer, accurately measure the patient's knee joint flexion and extension range of motion. During measurement, the patient is in the supine position. The axis of the goniometer is aligned with the lateral femoral condyle, the stationary arm is parallel to the long axis of the femur, and the movable arm is parallel to the long axis of the tibia. Record the angles at full knee extension (0°) and maximum flexion separately.
Measured: 24 and 48 hours after surgery
Total Opioid Consumption
Total postoperative consumption of opioids.
Measured: From the end of the surgery until 72 hours postoperatively
Postoperative Adverse Reactions
Including nausea and vomiting, urinary retention, constipation, puncture site ecchymosis and infection, as well as local anesthetic systemic toxicity.
Measured: From the end of the surgery until 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 posted29 May 2026
- Study start10 Jun 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion3 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TKAStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinli Ni, Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616102
- Sponsor's protocol ID
- Qiaojiang Shen-2026-03
- Acronym
- TKA
- Status last verified
- May 2026
- First submitted
- 27 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bupivacaine Liposome Adductor Canal Block on Muscle Strength After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT07616102
- Acronym / sponsor ID
- TKA / Qiaojiang Shen-2026-03
- Conditions
- TKA, Muscle Strength
- Keywords
- Bupivacaine Liposome, Adductor Canal Block, TKA, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 3 Nov 2026 (estimated)
- First posted
- 29 May 2026 (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.
This study employs a randomized controlled trial to investigate whether bupivacaine liposome injection for adductor canal block can effectively improve lower limb muscle strength after total knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) involves significant trauma, and postoperative patients often experience moderate to severe pain, which limits early knee joint functional exercise and affects functional recovery. Peripheral nerve blocks can effectively relieve pain, but while providing adequate analgesia, they may also affect the motor nerves of the lower limbs, increasing the risk of falls when patients begin ambulation. Some studies have found that the incidence of falls in patients using nerve blocks during the early postoperative period, especially during hospitalization, can be as high as 2% . The actual incidence in clinical practice may be even higher. The period of highest risk is when the nerve block effect has not completely subsided and patients begin attempting to ambulate, typically within 24 to 48 hours after surgery. The loss of muscle strength caused by motor nerve blockade is the most direct cause of postoperative falls, primarily due to severe weakness in key stabilizing muscle groups such as the quadriceps.The adductor canal block has clear advantages. However, traditional local anesthetics, represented by ropivacaine or bupivacaine, typically provide effective analgesia for only 12-24 hours after a single injection, making it difficult to fully cover the peak pain period of 48-72 hours postoperatively. Continuous femoral nerve block with ropivacaine can provide prolonged analgesia. When combined with a sciatic nerve block, it can achieve nearly complete analgesia coverage for the knee. Its drawback is its association with quadriceps impairment, which may increase the risk of falls. Continuous adductor canal block also provides prolonged analgesia and has a lesser impact on postoperative muscle strength, but it faces challenges such as catheter placement difficulty and inconvenience for postoperative mobility. In contrast, bupivacaine liposome can provide analgesia for up to 72 hours. If, while offering high-quality analgesia, bupivacaine liposome indeed causes significant weakening of quadriceps strength during the critical first 2-3 days after surgery, the safety and effectiveness of early patient ambulation would be greatly compromised, potentially even increasing the risk of falls. This would contradict the original intent of using the adductor canal block to preserve muscle strength. Conversely, if it is proven to have a lesser impact on muscle strength compared to continuous femoral nerve block, it could become an almost ideal analgesic option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a single-injection adductor canal block | Experimental | Procedure: a single-injection adductor canal blockAn ultrasound-guided adductor canal block is performed via the conventional adductor canal approach. Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal. |
| continuous femoral nerve block | Active comparator | Procedure: continuous femoral nerve blockAn ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach. A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 60-75 years scheduled for elective TKA;
- ASA physical status classification II-III;
- BMI 18-30 kg/m²;
- Agreement to participate in this study and provision of signed informed consent.
Key exclusion criteria (4 listed)
- Individuals with communication barriers such as language or hearing impairments;
- Patients with contraindications to nerve blocks;
- Severe systemic diseases, such as severe renal disease (estimated glomerular filtration rate below 50 mL/min), cardiac disease (congestive heart failure New York Heart Association Class III to IV), or severe hepatic disease defined as a current or past diagnosis of acute/subacute hepatic necrosis, acute liver failure, chronic liver disease, liver abscess, hepatic coma, or hepatorenal syndrome;
- History of long-term opioid use (defined as daily or nearly daily opioid use within the past 3 months).
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 |
|---|---|---|
| a single-injection adductor canal blockAn ultrasound-guided adductor canal block is performed via the conventional adductor canal approach. Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal. | Procedure or surgery | a single-injection adductor canal block |
| continuous femoral nerve blockAn ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach. A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine. | Procedure or surgery | continuous femoral nerve block |
Primary outcome
Quadriceps Muscle Strength
Time frame: 24 hours after surgery
The Maximum Voluntary Isometric Contraction (MVIC) test is used to assess quadriceps strength. The tester holds a handheld dynamometer. The patient sits on the bed with legs hanging naturally, and the knee is flexed to 60°. The patient is instructed to slowly exert force to extend the knee forward. As the patient exerts force, the tester applies an equal and opposite counterforce with the dynamometer to maintain the position and angle of the lower leg. The patient sustains maximum effort for 3-5 seconds, and the peak value displayed on the dynamometer is recorded as the result for that trial. Each leg is tested 2-3 times, with a 60-90 second rest between trials to prevent muscle fatigue from affecting the results. The average value is recorded as the final outcome. The unit of measurement is Newtons (N).
6 secondary outcomes
Quadriceps muscle strength at other time points
Time frame: 48 hours after surgery
Numeric Rating Scale (NRS) Score
Time frame: 24 and 48 hours after surgery
Quadriceps muscle strength grade
Time frame: 24 and 48 hours after surgery
Knee Joint Range of Motion
Time frame: 24 and 48 hours after surgery
Total Opioid Consumption
Time frame: From the end of the surgery until 72 hours postoperatively
Postoperative Adverse Reactions
Time frame: From the end of the surgery until 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 29 May 2026.
- Individual participant dataSharing planned: No
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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.
Xinli Ni study chair
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a single-injection adductor canal block and continuous femoral nerve block in people with TKA and Muscle Strength, run by General Hospital of Ningxia 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 May 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.
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 Xin li Ni, MD (13909586966, xinlii6@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Strength (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.