Analgesia After Total Knee Replacement Surgery

Study Overview
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Brief Summary
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Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome. Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.

Detailed Description
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Study design: Prospective randomised study Study population: Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study. Intervention: The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin. Primary study parameters/outcome of the study: NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest. Secondary study parameters/outcome of the study: Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.

Official Title
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Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Drug: naropin
* Drug: marcaine
* Drug: sufentanil
* Drug: neurontin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older and legally responsible Waiting for total knee replacement surgery Informed consent Exclusion Criteria: Contraindications for epidural analgesia Aortic Valve stenosis Severely compromised cardiac function infection near epidural punction site Redo knee surgery Previous arthrotomies Allergy/Hypersensitivity for study mediation or all other used medication Participation in other studies

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural analgesia<br>The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. | Drug: marcaine<br>* bupivacaine 0,125%<br>* Other names: bupivacaine;Drug: sufentanil<br>* sufentanil 1mcg/ml<br>* Other names: sufenta forte;|
| Active Comparator: local infiltration<br>The second group will receive local infiltration with ropivacaine of the knee during surgery. | Drug: naropin<br>* ropivacaine 0,2%, 3x 50 ml during surgery<br>* Other names: ropivacaine;|
| Active Comparator: local infiltration and gabapentin<br>The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin. | Drug: naropin<br>* ropivacaine 0,2%, 3x 50 ml during surgery<br>* Other names: ropivacaine;Drug: neurontin<br>* gabapentin 600 mg pre-operative 3 dd 300 mg<br>* Other names: gabapentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score in rest |  | 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of mobilisation |  | 3 days after surgery | 
| Postoperative morphine consumption | Daily morphine consumption (mg) per day | 3 days after surgery | 
| NRS score during flexion exercise |  | 3 days after surgery | 
| NRS score during walking exercise |  | 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural, Local infiltration, Knee, Arthroplasty