Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.

Detailed Description
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Primary Outcome Measures: Incidence of patients with significant pain on movement on day 1 post surgery Range of knee flexion Secondary Outcome Measures: Pain intensity (rest/movement) Functional recovery Knee Injury and Osteoarthritis Score Side effects/ Adverse outcomes SF12 Quality of Life Questionnaire Length of stay

Official Title
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Effects of Continuous Femoral Nerve Block Versus Single-Injection Femoral Nerve Block With Intravenous Patient Controlled Analgesia Versus Intravenous Patient Controlled Analgesia on Knee Pain and Function After Total Knee Replacement

Conditions
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Pain

Intervention / Treatment
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* Procedure: Continuous Femoral Nerve Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years and above Osteoarthritis Primary unilateral total knee replacement No other lower extremity joint disease ASA I-III Body mass index < 35 No severe cardiac or pulmonary diseases No chronic narcotic therapy or illicit drug use Mentally competent to understand study procedures and use of pain scales Able to provide informed consent Exclusion Criteria: Any cause for knee replacement other than osteoarthritis Total knee revision Any contraindication for femoral block Abnormal coagulation studies Thrombocytopenia less than 100,000/cc Known hepatic or renal insufficiency Neurological disease involving lower extremities Major surgery during the last 2 weeks pre-operatively History of allergy to study medications History of post-operative bleeding over 2000 cc/24 hours History of opioid or alcohol abuse Currently taking or has taken opioid > 30 consecutive days of daily use at a daily dose > 15mg morphine, within the past 2 weeks prior to surgery Previously has not responded to opioid analgesics for treatment of pain Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Femoral Nerve Block<br> | Procedure: Continuous Femoral Nerve Block<br>* 20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.<br>* Other names: Bupivacaine;|
| Active Comparator: Single-Inj Nerve Block with IV PCA<br> | Procedure: Continuous Femoral Nerve Block<br>* 20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.<br>* Other names: Bupivacaine;|
| Active Comparator: IV PCA<br> | Procedure: Continuous Femoral Nerve Block<br>* 20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients with significant pain on movement on day 1 post surgery |  | Post op day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional recovery |  | During hospitalization, week 2, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Replacement, Analgesia, Analgesics, Nerve blocks, Recovery of functions, Post operative analgesia