Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia

Study Overview
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Brief Summary
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Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?

Official Title
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Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia. A Randomized, Controlled Trial

Conditions
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Morbidity, Mortality, Complications, Function

Intervention / Treatment
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* Device: Femoral catheter
* Device: Epidural catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 -80 years ASA I-III Surgery: total knee replacement informed consent Exclusion Criteria: obesity contraindication for epidural anesthesia coagulation disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Femoral Block<br>One group received a femoral block for analgesia after surgery. Ropivacain was administered continuously for three days. | Device: Femoral catheter<br>* Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.<br>|
| Active Comparator: Epidural Analgesia<br>One group received an epidural analgesia after surgery for three days. | Device: Epidural catheter<br>* The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | 3 months after surgery the function of the total knee replacement is testd | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28 days after surgery | 
| Morbidity |  | 28 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural anesthesia, femoral block, patient control analgesia