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Local Infiltration Analgesia During Total Knee Arthroplasty

Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01305733
Acronym
LIA
Enrollment
60
Registered
2011-03-01
Start date
2011-03-31
Completion date
2012-12-31
Last updated
2012-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain relief

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).

Detailed description

The goal of LIA is to gain an effective and safe pain control during the first postoperative days. The study is a single-center, randomized controlled trial, which will be performed in Coxa Hospital for Joint Replacement in Tampere, Finland. The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. The RKA mixture is diluted with normal saline. Total volume of the solution is 100 ml depending on the size of the wound. The normal saline injection are used in the control group in the same manner than in the RKA group.

Interventions

DRUGThe injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline

The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline

OTHERsaline injection

saline

Sponsors

Coxa, Hospital for Joint Replacement
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients requiring primary TKA for primary OA * Patients aged 75 years or less * Patients suitable for all applicable devices

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
oxycodone consumption during the first 48 postoperative hours48 hours

Secondary

MeasureTime frame
functional outcome after TKA1 year

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026