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ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty

29. Juni 2026 aktualisiert von: Poznan University of Medical Sciences

Comparison of the Efficacy and Safety of Three Adjuvant Strategies for ACB and iPACK Blocks in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized Clinical Trial

This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine. Patients will be randomized into one of three groups: standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, or ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine added to both regional blocks.

The primary outcome will be total postoperative opioid consumption during the first 48 hours after surgery expressed as intravenous morphine equivalents. Secondary outcomes will include pain intensity at rest and during movement, duration of analgesia, time to first rescue analgesia, quadriceps muscle strength, early mobilization, adverse events, inflammatory markers, and length of hospital stay.

Studienübersicht

Detaillierte Beschreibung

Postoperative pain following total knee arthroplasty (TKA) remains a major clinical challenge and may negatively affect early mobilization, rehabilitation, patient satisfaction, and postoperative recovery. Inadequate pain control after TKA is associated with increased opioid consumption and opioid-related adverse events, including nausea, vomiting, sedation, urinary retention, respiratory depression, and postoperative delirium, particularly in elderly patients.

Ultrasound-guided Adductor Canal Block (ACB) combined with iPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block has become an increasingly popular regional anesthesia strategy for TKA because it may provide effective analgesia while preserving quadriceps muscle strength and facilitating early mobilization. The ACB primarily targets the sensory innervation of the anterior and medial aspects of the knee, whereas the iPACK block supplements analgesia of the posterior knee capsule.

Several adjuvant medications have been investigated to prolong the duration and improve the quality of peripheral nerve blocks. Intravenous dexamethasone is widely used as a perioperative analgesic adjunct and may prolong postoperative analgesia while also reducing postoperative nausea and vomiting. Perineural dexmedetomidine has been shown to prolong sensory blockade, improve analgesia quality, and reduce opioid requirements. However, the optimal combination of systemic and perineural adjuvants for ACB and iPACK blocks in TKA remains unclear.

The aim of this prospective randomized controlled trial is to compare three perioperative analgesic strategies in patients undergoing elective primary unilateral total knee arthroplasty under spinal anesthesia:

Standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine.

All participants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL). Ultrasound-guided ACB and iPACK blocks will be performed using 20 mL of 0.2% ropivacaine for each block. In the dexmedetomidine group, 12.5 µg of dexmedetomidine will be added to each regional block.

The primary endpoint of the study will be total postoperative opioid consumption during the first 48 postoperative hours expressed as intravenous morphine equivalents. Secondary endpoints will include postoperative pain scores at rest and during movement, time to first rescue analgesia, duration of analgesia, quadriceps muscle strength, early mobilization, opioid-related adverse events, dexmedetomidine-related adverse events such as bradycardia and hypotension, inflammatory markers, and length of hospital stay.

The study hypothesis is that intravenous dexamethasone will improve postoperative analgesia compared with standard ACB + iPACK alone, while the addition of low-dose perineural dexmedetomidine will further prolong analgesia duration and reduce opioid consumption without significantly increasing adverse events or impairing postoperative mobilization.

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Lublin, Polen
        • The John Paul II Catholic University of Lublin
        • Kontakt:
          • Michał Borys, MD PhD
      • Poznan, Polen, 62-701
        • Poznan University of Medical Sciences

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:

  • Age between 60 and 100 years
  • Scheduled for elective primary unilateral total knee arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand study procedures and provide written informed consent
  • Eligibility for spinal anesthesia and ultrasound-guided regional anesthesia according to institutional standards

Exclusion Criteria:

  • Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication
  • Contraindications to spinal anesthesia or peripheral nerve blocks
  • Coagulation disorders or anticoagulant therapy preventing safe regional anesthesia
  • Infection at the planned puncture site or systemic infection
  • Severe neurological disorders affecting lower limb sensory or motor function
  • Severe hepatic, renal, or uncontrolled cardiovascular disease
  • Clinically significant bradycardia or advanced atrioventricular conduction abnormalities
  • Chronic opioid use for more than 3 months before surgery
  • Uncontrolled diabetes mellitus or contraindications to dexamethasone administration
  • 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: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: ACB + iPACK Without Adjuvants
Participants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL) combined with ultrasound-guided Adductor Canal Block (ACB) and iPACK block using 20 mL of 0.2% ropivacaine for each block. No adjuvant medications will be administered. Standardized multimodal postoperative analgesia will be provided according to institutional protocol.
Ropivacaine 0.2% used for ultrasound-guided ACB and iPACK blocks (20 mL per block).
Andere Namen:
  • Ropimol
Experimental: ACB + iPACK With Intravenous Dexamethasone
Participants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL) combined with ultrasound-guided Adductor Canal Block (ACB) and iPACK block using 20 mL of 0.2% ropivacaine for each block. Intravenous dexamethasone 8 mg will be administered perioperatively. Standardized multimodal postoperative analgesia will be provided according to institutional protocol.
Intravenous dexamethasone 8 mg administered perioperatively.
Andere Namen:
  • Dexaven
Experimental: ACB + iPACK With Intravenous Dexamethasone and Perineural Dexmedetomidine
Participants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL) combined with ultrasound-guided Adductor Canal Block (ACB) and iPACK block using 20 mL of 0.2% ropivacaine for each block. Perineural dexmedetomidine 12.5 µg will be added to each regional block. Intravenous dexamethasone 8 mg will be administered perioperatively. Standardized multimodal postoperative analgesia will be provided according to institutional protocol.
Perineural dexmedetomidine 12.5 μg added to each regional block (ACB and iPACK).
Andere Namen:
  • Dexdor

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total postoperative opioid consumption during the first 48 hours after surgery
Zeitfenster: 48 hours after surgery
Total postoperative opioid consumption will be recorded during the first 48 hours after total knee arthroplasty and converted to intravenous morphine milligram equivalents.
48 hours after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain intensity at rest
Zeitfenster: 6 hours after surgery
Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
6 hours after surgery
Pain intensity at rest
Zeitfenster: 12 hours after surgery
Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
12 hours after surgery
Pain intensity at rest
Zeitfenster: 24 hours after surgery
Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
24 hours after surgery
Pain intensity at rest
Zeitfenster: 48 hours after surgery
Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
48 hours after surgery
Pain intensity during movement assessed using the Numeric Rating Scale
Zeitfenster: 6 hours postoperatively
Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.
6 hours postoperatively
Pain intensity during movement assessed using the Numeric Rating Scale
Zeitfenster: 12 hours postoperatively
Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.
12 hours postoperatively
Pain intensity during movement assessed using the Numeric Rating Scale
Zeitfenster: 24 hours postoperatively
Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.
24 hours postoperatively
Pain intensity during movement assessed using the Numeric Rating Scale
Zeitfenster: 48 hours postoperatively
Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.
48 hours postoperatively
Time to first rescue analgesia
Zeitfenster: 48 hours after surgery
Time from the end of surgery to the first request for or administration of rescue analgesic medication.
48 hours after surgery
Quadriceps muscle strength of the operated limb
Zeitfenster: 6 hours postoperatively
Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.
6 hours postoperatively
Quadriceps muscle strength of the operated limb
Zeitfenster: 12 hours postoperatively
Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.
12 hours postoperatively
Quadriceps muscle strength of the operated limb
Zeitfenster: 24 hours postoperatively
Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.
24 hours postoperatively
Quadriceps muscle strength of the operated limb
Zeitfenster: 48 hours postoperatively
Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.
48 hours postoperatively
Time to first postoperative mobilization
Zeitfenster: 48 hours postoperatively
Time from the end of surgery to the first successful mobilization with assistance, according to the institutional rehabilitation protocol.
48 hours postoperatively
Length of hospital stay
Zeitfenster: up to 7 days
Length of hospital stay will be defined as the number of days from surgery to hospital discharge.
up to 7 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences
  • Studienleiter: Michał Borys, MD PhD, The John Paul II Catholic University of Lublin

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)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the reported results will be made available to qualified researchers upon reasonable request after publication of the primary study results. Shared data may include demographic data, perioperative variables, postoperative pain scores, opioid consumption, adverse events, and other study-related outcomes. Data will be provided after removal of all direct identifiers in accordance with applicable data protection regulations.

IPD-Sharing-Zeitrahmen

Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.

IPD-Sharing-Zugriffskriterien

Access to de-identified participant data will be provided to researchers whose proposed use of the data has been approved by the principal investigators. Requests should include a methodologically sound research proposal. Data sharing agreements may be required before data release.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

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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