- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07677215
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Malgorzata Reysner, MD PhD
- Telefonnummer: +48 61 8310122
- E-mail: mreysner@ump.edu.pl
Undersøgelse Kontakt Backup
- Navn: Tomasz Reysner, MD PhD
- Telefonnummer: +48 61 8310122
- E-mail: treysner@ump.edu.pl
Studiesteder
-
-
-
Lublin, Polen
- The John Paul II Catholic University of Lublin
-
Kontakt:
- Michał Borys, MD PhD
-
Poznan, Polen, 62-701
- Poznan University of Medical Sciences
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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).
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
|
Eksperimentel: 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).
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total postoperative opioid consumption during the first 48 hours after surgery
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity at rest
Tidsramme: 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.
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6 hours after surgery
|
|
Pain intensity at rest
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 hours postoperatively
|
Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.
|
24 hours postoperatively
|
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Quadriceps muscle strength of the operated limb
Tidsramme: 48 hours postoperatively
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Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.
|
48 hours postoperatively
|
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Time to first postoperative mobilization
Tidsramme: 48 hours postoperatively
|
Time from the end of surgery to the first successful mobilization with assistance, according to the institutional rehabilitation protocol.
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48 hours postoperatively
|
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Length of hospital stay
Tidsramme: up to 7 days
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Length of hospital stay will be defined as the number of days from surgery to hospital discharge.
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up to 7 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences
- Studieleder: Michał Borys, MD PhD, The John Paul II Catholic University of Lublin
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Slidgigt
- Slidgigt, knæ
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Azoler
- Polycykliske forbindelser
- Imidazoler
- Anilider
- Amider
- Anilinforbindelser
- Aminer
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Ropivacain
- Dexamethason
- Dexmedetomidin
Andre undersøgelses-id-numre
- 6/2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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