Local Infiltration Analgesia During Total Knee Arthroplasty (LIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Coxa, Hospital for Joint Replacement.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Mika Niemeläinen, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier:
NCT01305733
First received: February 28, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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 Intervention
Pain
Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
Other: saline injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Coxa, Hospital for Joint Replacement:

Primary Outcome Measures:
  • oxycodone consumption during the first 48 postoperative hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • functional outcome after TKA [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mika Niemeläinen, orthopaedic surgeon, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT01305733     History of Changes
Other Study ID Numbers: Coxa - LIA
Study First Received: February 28, 2011
Last Updated: May 8, 2012
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

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

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

ClinicalTrials.gov processed this record on September 18, 2014