Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery

Study Overview
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Brief Summary
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Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.

Official Title
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Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia

Conditions
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Postoperative Pain, Knee Osteoarthritis

Intervention / Treatment
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* Drug: Ropivacaine 0.5% Injectable Solution
* Drug: Ropivacaine 0.2% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for a total knee arthroplasty under spinal block. Patient with a weight above 40kg. Exclusion Criteria: Patient with ASA IV status. Contraindication to spinal block, or peripheral nerve blocks. Neurological deficit of the lower limb. Patient with renal dysfunction. Patient with chronic pain, opioid consumption or alcohol consumption. Pregnancy.

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 |
| --- | --- |
| Experimental: Tibial nerve block<br>Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block. | Drug: Ropivacaine 0.5% Injectable Solution<br>* Tibial nerve block with 10ml of Ropivacaine 0.5%<br>|
| Active Comparator: Local infiltration analgesia<br>Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery. | Drug: Ropivacaine 0.2% Injectable Solution<br>* Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption (mg) |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption (mg) |  | 2 hours, 48 hours and 72 hours postoperatively | 
| Analgesic duration (minutes) | Time from the block to the first analgesic request | Postoperative day 0 | 
| Pain scores (numeric rating scale, 0-10) at rest and on movement | 0= no pain, 10=the worst pain imaginable | 2 hours, 24 hours, 48 hours and 72 hours postoperatively | 
| Rate of postoperative nausea and vomiting | Yes/No | 2 hours, 24 hours, 48 hours and 72 hours postoperatively | 
| Rate of prurit | Yes/No | 2 hours, 24 hours, 48 hours and 72 hours postoperatively | 
| Active flexion | Flexion of the knee by the patient measured in degrees | 24hours, 48hours and 72hours postoperatively | 
| Passive flexion | Flexion of the knee by physiotherapist measured in degrees | 24hours, 48hours and 72hours postoperatively | 
| Quadriceps muscle strength (numeric scale, 1-5) | 1=no contraction, 5=normal strength | 24hours, 48hours and 72hours postoperatively | 
| Distance walked (meters) |  | 24hours, 48hours and 72hours postoperatively | 
| Complication of tibial nerve block | Intravascular injection/hematoma/infection/Common peroneal nerve block | up to 1 week | 
| Length of stay in hospital | Days | up to 14 days |