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NCT Number: NCT07616102

Effect of Bupivacaine Liposome Injection 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.

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Key information

Conditions

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

a single-injection adductor canal block

Procedure

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 block

Procedure

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Quadriceps muscle strength at other time points

    Time frame: 48 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).

  2. Numeric Rating Scale (NRS) Score

    Time frame: 24 and 48 hours after surgery

    Using a scale from 0 to 10 to indicate pain intensity, where 0 represents no pain and 10 represents the worst possible pain.

  3. Quadriceps muscle strength grade

    Time frame: 24 and 48 hours after surgery

    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.

  4. Knee Joint Range of Motion

    Time frame: 24 and 48 hours after surgery

    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.

  5. Total Opioid Consumption

    Time frame: From the end of the surgery until 72 hours postoperatively

    Total postoperative consumption of opioids.

  6. Postoperative Adverse Reactions

    Time frame: From the end of the surgery until 72 hours postoperatively

    Including nausea and vomiting, urinary retention, constipation, puncture site ecchymosis and infection, as well as local anesthetic systemic toxicity.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiaojiang Shen

CONTACT

[email protected]

17829917323

Xin li Ni, MD

CONTACT

[email protected]

13909586966

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Effect of Bupivacaine Liposome Adductor Canal Block on Muscle Strength After Total Knee Arthroplasty.

Acronym: TKA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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