Local Infiltration Analgesia During Total Knee Arthroplasty
LIA
1 other identifier
interventional
60
1 country
2
Brief Summary
The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Mar 2011
Typical duration for not_applicable pain
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
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 9, 2012
May 1, 2012
1.2 years
February 28, 2011
May 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oxycodone consumption during the first 48 postoperative hours
48 hours
Secondary Outcomes (1)
functional outcome after TKA
1 year
Study Arms (2)
local infiltration analgesia
ACTIVE COMPARATORThe injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
saline injection
PLACEBO COMPARATORThe normal saline injection are used in the control group in the same manner than in the RKA group.
Interventions
The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
Eligibility Criteria
You may qualify if:
- Patients requiring primary TKA for primary OA
- Patients aged 75 years or less
- Patients suitable for all applicable devices
You may not qualify if:
- Rheumatoid arthritis or other inflammatory diseases
- Patients requiring bone grafting during surgery
- Unwilling to provide informed consent
- BMI \> 35
- ASA \> 3
- Renal dysfunction
- Allergic to ASA
- Previous high tibial osteotomy or previous osteosynthesis
- \> 15 degrees varus / valgus malalignment
- Physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
- Known sensitivity to materials in the devices
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Coxa - hospital for joint replacement
Tampere, Pirkanmaa, 33560, Finland
COXA
Tampere, Pirkanmaa, 33560, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antti Eskelinen, M.D., Ph.D
Coxa, Hospital for Joint Replacement
- PRINCIPAL INVESTIGATOR
Mika Niemeläinen, MD
Coxa, Hospital for Joint Replacement
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- orthopaedic surgeon
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 1, 2011
Study Start
March 1, 2011
Primary Completion
May 1, 2012
Study Completion
December 1, 2012
Last Updated
May 9, 2012
Record last verified: 2012-05