Overview

This trial is active, not recruiting.

Condition pain
Treatments the injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline, saline injection
Sponsor Coxa, Hospital for Joint Replacement
Start date March 2011
End date May 2012
Trial size 60 participants
Trial identifier NCT01305733, Coxa - LIA

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
The 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
The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
(Placebo Comparator)
The normal saline injection are used in the control group in the same manner than in the RKA group.
saline injection
saline

Primary Outcomes

Measure
oxycodone consumption during the first 48 postoperative hours
time frame: 48 hours

Secondary Outcomes

Measure
functional outcome after TKA
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial
Principal investigator Mika Niemeläinen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Coxa, Hospital for Joint Replacement.