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

29. června 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Malgorzata Reysner, MD PhD
  • Telefonní číslo: +48 61 8310122
  • E-mail: mreysner@ump.edu.pl

Studijní záloha kontaktů

  • Jméno: Tomasz Reysner, MD PhD
  • Telefonní číslo: +48 61 8310122
  • E-mail: treysner@ump.edu.pl

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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).
Ostatní jména:
  • Ropimol
Experimentální: 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.
Ostatní jména:
  • Dexaven
Experimentální: 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).
Ostatní jména:
  • Dexdor

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total postoperative opioid consumption during the first 48 hours after surgery
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain intensity at rest
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Studijní židle: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences
  • Ředitel studie: Michał Borys, MD PhD, The John Paul II Catholic University of Lublin

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. září 2027

Dokončení studie (Odhadovaný)

1. října 2027

Termíny zápisu do studia

První předloženo

20. května 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

30. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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