Persistent Post Surgical Pain After Total Knee Arthroplasty

Study Overview
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Brief Summary
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Patients undergone total knee replacement are randomized to receive a fast track regional anesthesia protocol or a traditional regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery

Detailed Description
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Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.

Official Title
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Enhanced Recovery After Surgery and Total Knee Replacement: A Prospective, Randomized Study on the Rule of Peripheral Nerve Blocks on Persistent Postoperative Pain Six Months After Surgery

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Procedure: continuous peripheral nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary total knee replacement with a written informed consent Exclusion Criteria: Allergy to local anesthetics or any drugs involve in the study Controindication to regional anesthesia chronic use of opioids BMI > 35 kg m2

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fast track<br>continuous adductor canal block and ipack block | Procedure: continuous peripheral nerve block<br>* continuous regional anesthesia in total knee replacement<br>|
| Experimental: traditional<br>continuous femoral nerve block and continuous sciatic block | Procedure: continuous peripheral nerve block<br>* continuous regional anesthesia in total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent post surgical pain | Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement | 0-6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute postoperative pain | Numeric rating score (0-10) over 4 in POD0, POD1, POD2, POD3 | 0-72 hours | 
| Morphine requirement | total morphine administration via PCA in POD0, POD1, POD2, POD3 | 0-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee arthroplasty, acute postoperative pain, persistent post surgical pain, regional anesthesia