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

29 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Malgorzata Reysner, MD PhD
  • Numero di telefono: +48 61 8310122
  • Email: mreysner@ump.edu.pl

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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).
Altri nomi:
  • Ropimolo
Sperimentale: 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.
Altri nomi:
  • Dexaven
Sperimentale: 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).
Altri nomi:
  • Dexdor

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total postoperative opioid consumption during the first 48 hours after surgery
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain intensity at rest
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences
  • Direttore dello studio: Michał Borys, MD PhD, The John Paul II Catholic University of Lublin

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

20 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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