ESPB vs iPACK+ACB in Total Knee Arthroplasty
Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement
1 other identifier
interventional
60
1 country
1
Brief Summary
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and 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 Apr 2024
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
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMarch 8, 2024
March 1, 2024
6 months
March 4, 2024
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Opioid consumption
Total opiate consumption after surgery
48 hours after surgery
Secondary Outcomes (14)
Time to first rescue opiate analgesia
48 hours after procedure
Numerical Rating Scale [range 0:10]
Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 16 hours after surgery
- +9 more secondary outcomes
Study Arms (3)
iPACK + ACB
ACTIVE COMPARATORspinal anesthesia \+ ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)
Erectro Spinae Plane Block
ACTIVE COMPARATORspinal anesthesia \+ ultrasound guided ESPBk - 20ml 0,2% ropivacaine
Control group
PLACEBO COMPARATOROnly spinal anesthesia - No peripheral nerve block
Interventions
iPACK block + Adductor Canal Block
Eligibility Criteria
You may qualify if:
- Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.
You may not qualify if:
- patients who have a history of bleeding diathesis,
- take anticoagulant therapy,
- have a History of chronic pain before surgery,
- have Multiple trauma, cannot assess their pain (dementia),
- have been operated on under general anaesthesia,
- have an infection in the area and 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
- STUDY CHAIR
Łukasz Łapaj, Ph.D.
Poznań University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 8, 2024
Study Start
April 1, 2024
Primary Completion
September 30, 2024
Study Completion
October 30, 2025
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 6 month after study completion
- Access Criteria
- from the corresponding author on the resonable request