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
1 other identifier
interventional
120
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jul 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
June 30, 2026
May 1, 2026
1.2 years
May 20, 2026
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total postoperative opioid consumption during the first 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
Secondary Outcomes (15)
Pain intensity at rest
6 hours after surgery
Pain intensity at rest
12 hours after surgery
Pain intensity at rest
24 hours after surgery
Pain intensity at rest
48 hours after surgery
Pain intensity during movement assessed using the Numeric Rating Scale
6 hours postoperatively
- +10 more secondary outcomes
Study Arms (3)
ACB + iPACK Without Adjuvants
ACTIVE COMPARATORParticipants 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.
ACB + iPACK With Intravenous Dexamethasone
EXPERIMENTALParticipants 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.
ACB + iPACK With Intravenous Dexamethasone and Perineural Dexmedetomidine
EXPERIMENTALParticipants 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.
Interventions
Intravenous dexamethasone 8 mg administered perioperatively.
Ropivacaine 0.2% used for ultrasound-guided ACB and iPACK blocks (20 mL per block).
Perineural dexmedetomidine 12.5 μg added to each regional block (ACB and iPACK).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The John Paul II Catholic University of Lublin
Lublin, Poland
Poznan University of Medical Sciences
Poznan, 62-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malgorzata Reysner, MD PhD
Poznan University of Medical Sciences
- STUDY DIRECTOR
Michał Borys, MD PhD
The John Paul II Catholic University of Lublin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2026
First Posted
June 30, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
June 30, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
- Access Criteria
- 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.
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.