LIA: Local Infiltration Analgesia During Total Knee Arthroplasty

• Sponsor: Coxa, Hospital for Joint Replacement (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01305733
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 21.1
• Patients Per Site: 30
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Mar 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. oxycodone consumption during the first 48 postoperative hours [48 hours]

Secondary Outcome Measures

1. functional outcome after TKA [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coxa - hospital for joint replacement	Tampere	Pirkanmaa	Finland	33560
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mika Niemeläinen, orthopaedic surgeon, Coxa, Hospital for Joint Replacement
• ClinicalTrials.gov Identifier: NCT01305733
• Other Study ID Numbers: Coxa - LIA
• First Posted: Mar 1, 2011
• Last Update Posted: May 9, 2012
• Last Verified: May 1, 2012

• Keywords provided by Mika Niemeläinen, orthopaedic surgeon, Coxa, Hospital for Joint Replacement: Pain relief
• Additional relevant MeSH terms: Ketorolac; Epinephrine; Racepinephrine; Levobupivacaine; Epinephryl borate

Study Results

No Results Posted as of May 9, 2012