Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

Study Overview
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Brief Summary
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Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.

Official Title
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Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: Adductor canal
* Procedure: Femoral
* Procedure: Spinal Anesthesia
* Procedure: Local anesthetic infusion
* Procedure: Intravenous analgesia
* Drug: Ropivacaine 0,75%
* Drug: Levobupivacaine 0,5%
* Drug: Levobupivacaine 0,125%
* Drug: Ketorolac 30mg
* Drug: Morphine
* Device: stimulong sono, Pajunk, Germany


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing total knee arthroplasty Exclusion Criteria: diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adductor canal<br>All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected. | Procedure: Adductor canal<br>* Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.<br>Procedure: Spinal Anesthesia<br>* Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.<br>Procedure: Local anesthetic infusion<br>* Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.<br>Procedure: Intravenous analgesia<br>* Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.<br>Drug: Ropivacaine 0,75%<br> <br> Drug: Levobupivacaine 0,5%<br> <br> Drug: Levobupivacaine 0,125%<br> <br> Drug: Ketorolac 30mg<br> <br> Drug: Morphine<br> <br> Device: stimulong sono, Pajunk, Germany<br> <br> |
| Active Comparator: Femoral<br>All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve. | Procedure: Femoral<br>* Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.<br>Procedure: Spinal Anesthesia<br>* Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.<br>Procedure: Local anesthetic infusion<br>* Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.<br>Procedure: Intravenous analgesia<br>* Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.<br>Drug: Ropivacaine 0,75%<br> <br> Drug: Levobupivacaine 0,5%<br> <br> Drug: Levobupivacaine 0,125%<br> <br> Drug: Ketorolac 30mg<br> <br> Drug: Morphine<br> <br> Device: stimulong sono, Pajunk, Germany<br> <br> |
| Placebo Comparator: Controls<br>No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered. | Procedure: Spinal Anesthesia<br>* Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.<br>Procedure: Intravenous analgesia<br>* Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.<br>Drug: Levobupivacaine 0,5%<br> <br> Drug: Ketorolac 30mg<br> <br> Drug: Morphine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Up and Go test | Knee functional evaluation at 5th postoperative day. up and go test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair | 5th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | Evaluation of VAS static and VAS dynamic during hospital stay | up to POD5 | 
| Morphine request | Opioids consumption will be recorded throughout postoperative period | up to POD5 | 
| Range of motion | Physiotherapist measures the maximum active/passive range of motion | 5th postoperative day | 
| Falling risk | Evaluation of falling risk with Berg Balance Scale | 5th postoperative day | 
| Quadriceps strength | evaluate muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°. | 5th postoperative day |