- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07616102
Effect of Bupivacaine Liposome Injection on Muscle Strength After Total Knee Arthroplasty (TKA)
26. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
80
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Xin li Ni, MD
- Telefonnummer: 13909586966
- E-Mail: xinlii6@nyfy.com.cn
Studieren Sie die Kontaktsicherung
- Name: Qiaojiang Shen
- Telefonnummer: 17829917323
- E-Mail: 2832394521@qq.com
Studienorte
-
-
Ningxia
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Yinchuan, Ningxia, China
- General Hospital of Ningxia Medical University
-
Kontakt:
- Xinli Ni, MD
- Telefonnummer: 86-0951-6743252
- E-Mail: xinlini6@nyfy.com.cn
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
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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.
|
|
Aktiver 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.
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quadriceps Muscle Strength
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quadriceps muscle strength at other time points
Zeitfenster: 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
|
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Numeric Rating Scale (NRS) Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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Postoperative Adverse Reactions
Zeitfenster: From the end of the surgery until 72 hours postoperatively
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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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Xinli Ni, General Hospital of Ningxia Medical University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
10. Juni 2026
Primärer Abschluss (Geschätzt)
30. Oktober 2026
Studienabschluss (Geschätzt)
3. November 2026
Studienanmeldedaten
Zuerst eingereicht
27. März 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Mai 2026
Zuerst gepostet (Tatsächlich)
29. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Qiaojiang Shen-2026-03
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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