NLR and PLR Levels Following IPACK Block in Knee Arthroplasty
The Neutrophil-to-lymphocyte Ratio (NLR) and Platelet-to-lymphocyte Ratio (PLR) Levels Following IPACK Block in Knee Arthroplasty: a Randomized, Controlled Trial.
1 other identifier
interventional
60
1 country
1
Brief Summary
Effect of iPACK block on NLR and PLR following 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
Started Mar 2024
Shorter than P25 for phase_4
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
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedStudy Start
First participant enrolled
March 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2025
CompletedMarch 24, 2025
March 1, 2025
10 months
May 24, 2023
March 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Neutrophil-to-lymphocyte ratio
Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.
12 hours after surgery
Secondary Outcomes (14)
PLR
12 hours after surgery
PLR
24 hours after surgery
PLR
48 hours after surgery
NLR
24 hours after surgery
NLR
48 hours after surgery
- +9 more secondary outcomes
Study Arms (2)
Sham blocks
ACTIVE COMPARATORiPACK block with 20ml of 0.9% sodium chloride
iPACK block
ACTIVE COMPARATORiPACK block with 20ml 0f 0.2% ropivacaine
Interventions
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine
Eligibility Criteria
You may qualify if:
- Patients with ASA classification I-III
- Aged 20-90 years
- Who will be scheduled for hip arthroplasty under spinal anesthesia
You may not qualify if:
- Patients who have a history of bleeding diathesis
- Take anticoagulant therapy
- History of chronic pain before surgery
- Multiple trauma
- patients unable to assess their pain (dementia)
- patients operated under general anesthesia
- patients having an infection in region of the procedure
- patient who do not accept the procedure
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
- PRINCIPAL INVESTIGATOR
Małgorzata Domagalska, Ph.D.
Poznań University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
March 12, 2024
Study Start
March 30, 2024
Primary Completion
January 16, 2025
Study Completion
February 10, 2025
Last Updated
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share