Local Infiltration Analgesia During Total Knee Arthroplasty

NCT ID: NCT01305733

Last Updated: 2012-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-12-31

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).

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

local infiltration analgesia

The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline

Group Type: ACTIVE_COMPARATOR

The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline

Intervention Type: DRUG

The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline

saline injection

The normal saline injection are used in the control group in the same manner than in the RKA group.

Group Type: PLACEBO_COMPARATOR

saline injection

Intervention Type: OTHER

saline

Interventions

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

Intervention Type: DRUG

saline injection

saline

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coxa, Hospital for Joint Replacement

OTHER

Sponsor Role: lead

Responsible Party

Mika Niemeläinen

orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antti Eskelinen, M.D., Ph.D

Role: STUDY_DIRECTOR

Coxa, Hospital for Joint Replacement

Mika Niemeläinen, MD

Role: PRINCIPAL_INVESTIGATOR

Coxa, Hospital for Joint Replacement

Locations

Coxa - hospital for joint replacement

Tampere, Pirkanmaa, Finland

COXA

Tampere, Pirkanmaa, Finland

Countries

Finland

Other Identifiers

Coxa - LIA

Identifier Type: -

Identifier Source: org_study_id