- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07595471
Proximal Spread in Adductor Canal Block(ACB) (ACB)
12. Mai 2026 aktualisiert von: Müge Çakırca, Ankara Etlik City Hospital
The Impact of Injection Level on the Proximal Spread of Local Anesthetic and Clinical Outcomes in Adductor Canal Block
This prospective, randomized clinical study is designed to evaluate the effects of two different injection levels of adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty.
The study will be conducted at Ankara Etlik City Hospital and will include a total of 68 patients.
All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia.
In this study, the comparison will be based on the application of adductor canal block at two distinct injection levels.
In both groups, blocks will be performed under ultrasound (USG) guidance using the same technical principles and standardized conditions; in the first group, the block will be administered at the level where the vasto-adductor membrane is first visualized, while in the second group, it will be performed at the level where the adductor longus ends.
The type, concentration, and volume of local anesthetic used in both groups will be standardized as 20 mL of 0.25% bupivacaine.
The groups will be compared in terms of the proximal spread of the local anesthetic based on the injection level, the area of spread at the apex of the iliopectineal fossa, the involvement of the femoral nerve, the incidence of postoperative falls, and analgesic consumption.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Detaillierte Beschreibung
This prospective, randomized clinical trial is designed to evaluate the effects of two distinct injection levels of ultrasound-guided adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty (TKA).
The study will be conducted at Ankara Etlik City Hospital with a total of 68 patients.
All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia.
Inclusion and Exclusion Criteria Inclusion criteria are defined as patients aged 18 years and older, with an ASA (American Society of Anesthesiologists) physical status of I-III, scheduled for elective unilateral TKA under spinal anesthesia.
Exclusion criteria include patients scheduled for bilateral knee arthroplasty, known allergy to local anesthetics, chronic pain syndromes or regular opioid use, peripheral neuropathy or neurological diseases affecting femoral nerve function, coagulopathy or use of anticoagulant therapy, infection at the injection site, and patients unable to provide written informed consent.
Randomization and Intervention Patients will be randomized into two groups using the sealed envelope method.
In Group 1, the ACB will be performed under ultrasound (USG) guidance at the level where the vasto-adductor membrane (VAM) is first visualized.
In Group 2, the block will be performed at the level where the adductor longus muscle ends.
All blocks will be administered by experienced anesthesiologists using a standardized dose of 20 mL 0.25% bupivacaine.
Clinicians performing the block will not be involved in the postoperative data collection process.
Procedure and Monitoring All patients will undergo standard monitoring, including electrocardiography (EKG), non-invasive arterial blood pressure, and peripheral oxygen saturation (SpO_2).
Following the administration of spinal anesthesia according to clinical protocols, the ACB will be performed under USG guidance based on the randomization results.
Standard care will be provided throughout the surgical and anesthetic management, and perioperative data will be recorded.
Outcome Measures and Evaluation Following the block, the spread of the local anesthetic will be evaluated in real-time using ultrasound.
The distance between the injection point and the highest proximal point of the anesthetic spread will be measured in centimeters.
Additionally, the spread area of the local anesthetic at the level of the apex of the iliopectineal fossa will be recorded using the planimetric measurement tools of the USG device.
The reach of the local anesthetic to the femoral nerve will also be assessed via USG.
Postoperatively, patients will follow standard clinical monitoring.
Motor block will be evaluated based on the incidence of postoperative falls (yes/no).
Sensory block efficacy will be assessed through total analgesic consumption recorded within the first 24 hours postoperatively.
All collected data will be recorded for statistical analysis and compared based on the injection levels.
Studientyp
Interventionell
Einschreibung (Geschätzt)
68
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ankara, Türkei (türkiye), 06000
- Ankara Etlik City Hospital
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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 > 18 years.
- ASA physical status classification I-III.
- Patients scheduled for elective, unilateral total knee arthroplasty (TKA).
- Planned administration of spinal anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:Scheduled for bilateral knee arthroplasty.
- Known hypersensitivity or allergy to local anesthetics.
- History of chronic pain syndrome or regular opioid consumption.
- Presence of peripheral neuropathy or neurological disorders affecting the femoral nerve.
- Coagulopathy or ongoing anticoagulant therapy.
- Active infection at the site of injection.
- Inability or refusal to provide written informed consent.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Group 1: ACB at the proximal vasto-adductor membrane level (20 mL 0.25% bupivacaine)
Group 1: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the vasto-adductor membrane is first visualized.
|
In this study, patients were evaluated using two distinct approaches based on the evolution of anatomical definitions in recent literature: the proximal application, traditionally referred to as the adductor canal block but now more accurately defined as the 'Femoral Triangle Block' in current publications,
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Aktiver Komparator: Group 2: Level of the end of the adductor longus
Group 2: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the adductor longus muscle ends.
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In this study, patients were evaluated using two distinct approaches based on the evolution of anatomical definitions in recent literature: the proximal application, traditionally referred to as the adductor canal block but now more accurately defined as the true 'Distal Adductor Canal Block' performed in accordance with contemporary anatomical criteria."
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proximal spread of local anesthetic
Zeitfenster: The first postoperative hour
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The primary objective of this study is to compare the proximal spread of local anesthetic following ultrasound-guided adductor canal block performed at two distinct injection levels.
In the first group, the injection will be administered at the level where the vastoadductor membrane is first visualized ultrasonographically in the proximal region.
In the second group, the injection will be performed at the level where the adductor magnus and sartorius muscles first intersect.In both patient groups, the area of local anesthetic spread at the apex of the iliopectineal fossa will be measured in $cm^2$ using ultrasonography.
Additionally, the distance between the needle insertion point (injection level) and the apex of the iliopectineal fossa, as well as the distance from the needle insertion point to the most proximal point where the local anesthetic is ultrasonographically visualized, will be recorded in cm.
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The first postoperative hour
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain Scores (Numeric Rating Scale)
Zeitfenster: post-op hours 6 and 24
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Evaluation of NRS(Numeric Rating Scale) scores at the 6th and 24th postoperative hours.The Numerical Rating Scale (NRS) is a common subjective clinical tool that requires patients to quantify their pain intensity on a scale ranging from 0 to 10
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post-op hours 6 and 24
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Assessment of Motor Block
Zeitfenster: Postoperative 24th hours
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Motor block and falls were evaluated at the 24th hour.Ambulation was assessed within the first 24 hours postoperatively.
Successful ambulation was defined as the ability to walk without falling; patients who failed to ambulate or suffered a fall during the attempt were categorized as 'treatment failure'.
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Postoperative 24th hours
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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 (Tatsächlich)
7. April 2026
Primärer Abschluss (Geschätzt)
30. Mai 2026
Studienabschluss (Geschätzt)
1. Juni 2026
Studienanmeldedaten
Zuerst eingereicht
7. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Mai 2026
Zuerst gepostet (Tatsächlich)
19. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2024-KAEK-40 (Ankara Etlik City Hospital Clinical Research Ethics Committee)
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
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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