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Local Infiltration Analgesia During Total Knee Arthroplasty (LIA)

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ClinicalTrials.gov Identifier: NCT01305733
Recruitment Status : Unknown
Verified May 2012 by Mika Niemeläinen, Coxa, Hospital for Joint Replacement.
Recruitment status was:  Active, not recruiting
First Posted : March 1, 2011
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):
Mika Niemeläinen, Coxa, Hospital for Joint Replacement

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).

Condition or disease Intervention/treatment Phase
Pain Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline Other: saline injection Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial
Study Start Date : March 2011
Actual Primary Completion Date : May 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Ketorolac

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




Primary Outcome Measures :
  1. oxycodone consumption during the first 48 postoperative hours [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. functional outcome after TKA [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305733


Locations
Finland
Coxa - hospital for joint replacement
Tampere, Pirkanmaa, Finland, 33560
COXA
Tampere, Pirkanmaa, Finland, 33560
Sponsors and Collaborators
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

Responsible Party: Mika Niemeläinen, orthopaedic surgeon, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT01305733     History of Changes
Other Study ID Numbers: Coxa - LIA
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Mika Niemeläinen, Coxa, Hospital for Joint Replacement:
Pain relief

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Levobupivacaine
Bupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents