Dexamethasone for iPACK Block With ACB in Total Knee Arthroplasty
Infiltration Between the Popliteal Artery and Capsule of the Knee Block With Adductor Canal Block With Ropivacaine vs Ropivacaine and Dexamethasone in Total Knee Arthroplasty: A Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Effect of adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 knee-osteoarthritis
Started Aug 2024
Shorter than P25 for phase_4 knee-osteoarthritis
1 active site
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
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2025
CompletedJuly 23, 2025
March 1, 2025
6 months
June 17, 2024
July 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
48 hours after surgery
Secondary Outcomes (17)
Total Opioid Consumption
48 hours after surgery
Numerical Rating Scale [range 0:10]
4 hours after surgery
Numerical Rating Scale [range 0:10]
8 hours after surgery
Numerical Rating Scale [range 0:10]
12 hours after surgery
Numerical Rating Scale [range 0:10]
24 hours after surgery
- +12 more secondary outcomes
Study Arms (2)
Ropivacaine
ACTIVE COMPARATORiPACK Block + ACB with Ropivacaine
Ropivacaine + Dexamethasone
ACTIVE COMPARATORiPACK Block + ACB with Ropivacaine + Dexamethasone
Interventions
Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2ml 0.9% NaCl)
Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2mg Dexamethasone)
Eligibility Criteria
You may qualify if:
- patients scheduled for total hip arthroplasty
- patients aged \>65 and \<100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
You may not qualify if:
- inability to provide first-party consent due to cognitive impairment or a language barrier
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, Poznań, 61-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malgorzata Reysner, M.D. Ph.D.
Poznań University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
June 17, 2024
First Posted
June 24, 2024
Study Start
August 13, 2024
Primary Completion
January 31, 2025
Study Completion
March 30, 2025
Last Updated
July 23, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Following the trial completion
- Access Criteria
- Elligible researcher
Individual participant data will be available to eligible researchers following the trial completion