Local Infiltration Analgesia During Total Knee Arthroplasty (LIA)

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

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).

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline; Other: saline injection

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33560
      • Coxa - hospital for joint replacement
    • Tampere, Pirkanmaa, Finland, 33560
      • COXA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: local infiltration analgesia; The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline	Drug: 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: saline injection; The normal saline injection are used in the control group in the same manner than in the RKA group.	Other: saline injection; saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
oxycodone consumption during the first 48 postoperative hours	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
functional outcome after TKA	1 year

Collaborators and Investigators

• Sponsor: Coxa, Hospital for Joint Replacement
• Investigators: Study Director: Antti Eskelinen, M.D., Ph.D, Coxa, Hospital for Joint Replacement; Principal Investigator: Mika Niemeläinen, MD, Coxa, Hospital for Joint Replacement

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 1, 2011

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Pain relief
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ketorolac; Levobupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: Coxa - LIA