- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07616102
Effect of Bupivacaine Liposome Injection on Muscle Strength After Total Knee Arthroplasty (TKA)
26. maj 2026 opdateret af: General Hospital of Ningxia Medical University
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xin li Ni, MD
- Telefonnummer: 13909586966
- E-mail: xinlii6@nyfy.com.cn
Undersøgelse Kontakt Backup
- Navn: Qiaojiang Shen
- Telefonnummer: 17829917323
- E-mail: 2832394521@qq.com
Studiesteder
-
-
Ningxia
-
Yinchuan, Ningxia, Kina
- General Hospital of Ningxia Medical University
-
Kontakt:
- Xinli Ni, MD
- Telefonnummer: 86-0951-6743252
- E-mail: xinlini6@nyfy.com.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: a single-injection adductor canal block
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.
|
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.
|
|
Aktiv komparator: continuous femoral nerve block
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quadriceps Muscle Strength
Tidsramme: 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).
|
24 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quadriceps muscle strength at other time points
Tidsramme: 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).
|
48 hours after surgery
|
|
Numeric Rating Scale (NRS) Score
Tidsramme: 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.
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24 and 48 hours after surgery
|
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Quadriceps muscle strength grade
Tidsramme: 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.
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24 and 48 hours after surgery
|
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Knee Joint Range of Motion
Tidsramme: 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.
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24 and 48 hours after surgery
|
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Total Opioid Consumption
Tidsramme: From the end of the surgery until 72 hours postoperatively
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Total postoperative consumption of opioids.
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From the end of the surgery until 72 hours postoperatively
|
|
Postoperative Adverse Reactions
Tidsramme: 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.
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From the end of the surgery until 72 hours postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Xinli Ni, General Hospital of Ningxia Medical University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. juni 2026
Primær færdiggørelse (Anslået)
30. oktober 2026
Studieafslutning (Anslået)
3. november 2026
Datoer for studieregistrering
Først indsendt
27. marts 2026
Først indsendt, der opfyldte QC-kriterier
26. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Qiaojiang Shen-2026-03
Plan for individuelle deltagerdata (IPD)
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