Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

Study Overview
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Brief Summary
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The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.

Detailed Description
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Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one. In this study we will compare two well established methods of pain treatment: continuous infusion of local anesthetics + opioids into the epidural space, patient controlled analgesia with IV Morphine. The study design is double blind. Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively. Pain scores, total analgesic medications other than study medications, adverse reactions to study medications, complications and patient satisfaction will be followed by blinded observers and compared between groups.

Official Title
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Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

Conditions
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Pain, Postoperative, Osteoarthritis

Intervention / Treatment
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* Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml
* Drug: Morphine sulphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Age: 55 to 85 years Osteoarthritis Primary unilateral total knee replacement American Society of Anesthesiologists (ASA) I-III Successful spinal epidural anesthesia for surgery Exclusion Criteria: Any cause for knee replacement other than osteoarthritis Total knee revision (re-do) Any contraindication for regional anesthesia Abnormal coagulation studies Thrombocytopenia less than 100,000/cc Chronic renal failure (creatinine [cr] < 1.8) Neurological disease involving lower extremities Major surgery during the last 2 weeks pre-operatively Current or past drug or alcohol abuse Allergy to study medications Post-operative bleeding over 2000 cc/24 hours Postdural puncture headache after anesthesia performance

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml|nan|
|Drug: Morphine sulphate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation |  |  | 
| Total dose of rescue analgesics during first 24 hours post-operation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge |  |  | 
| Patient outcome questionnaire |  |  | 
| Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension) |  |  | 
| Adverse reactions, complications |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee replacement, orthopedic surgery, post operative analgesia, continuous epidural, patients controlled analgesia, morphine, combined spinal epidural anesthesia, anesthesia, analgesia, epidural marcaine, epidural fentanyl, pain