Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

Study Overview
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Brief Summary
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This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

Detailed Description
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This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

Official Title
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Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.

Conditions
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Postoperative Pain, Postoperative Complications

Intervention / Treatment
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* Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
* Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admitted for unilateral primary total knee arthroplasty. Exclusion Criteria: ASA score > 3 BMI > 40 refusal of loco-regional technique. psychiatric disease. inability to understand/ use the Local anesthetic delivery pump. local anesthetic allergy, porphyry, uncontrolled epilepsy, severe cardiac arrhythmia.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continous infusion ropivacaine<br>Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ... | Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)<br>* continuous infusion 6ml/h<br>* Other names: Continuous infusion;|
| Experimental: PIB ropivacaine<br>Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ... | Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)<br>* programmed intermittent bolus 5ml each one hour.<br>* Other names: PIB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of unplanned analgesia interventions. | Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period. | up to 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain difference | Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement. | up to 72 hours after surgery | 
| Motor block frequency | Accessed by physiotherapist twice a day, by testing the Quadriceps muscle. | up to 72 hours after surgery | 
| Mobilization quality during physiotherapy sessions. | accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee). | up to 72 hours after surgery | 
| local anesthesia technique related complications | rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events. | until catheter removal 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, postoperative pain, programmed intermittent bolus, Continuous femoral nerve block