Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are: Continuous femoral nerve block with ultrasound guided posterior capsular injection Continuous femoral nerve block with ultrasound selective tibial nerve block.

Detailed Description
-----------------
Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery. The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.

Official Title
-----------------
Assessment of Knee Pain in Patients Receiving Continuous Femoral Nerve Block Combined With Either Ultrasound Guided Posterior Capsular Injection or Selective Tibial Nerve Block Following Total Knee Arthroplasty

Conditions
-----------------
Posterior Knee Infiltration

Intervention / Treatment
-----------------
* Drug: Ropivacaine with Epinephrine
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having primary, unilateral total knee arthroplasty Age 18-80 Exclusion Criteria: History of neurologic disease, neuropathy, diabetes, or major systemic illness Allergy to local anesthetic solution or NSAIDs Pregnancy Chronic use of narcotics Inability to give consent/cooperate with study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior capsular injection<br>Ultrasound guided posterior capsular injection of ropivacaine with epinephrine | Drug: Ropivacaine with Epinephrine<br>* Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles<br>* Other names: Adrenalin;|
| Active Comparator: Tibial nerve block<br>Ultrasound selective tibial nerve block of ropivacaine | Drug: Ropivacaine<br>* Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa<br>* Other names: Naropin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery | 48 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Amount of opioid used for the first 24 hours post surgery | 24 hours post surgery | 
| Plantar Flexion in the Tibial Nerve Distribution | Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block) | Upon emergence from anesthesia in the PACU | 
| Cold Sensation in the Tibial Nerve Distribution | Number of participants with a self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block) | Upon emergence from anesthesia in the PACU | 
| Dorsiflexion in the Peroneal Nerve Distribution | Number of participants with a blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block) | Upon emergence from anesthesia in the PACU | 
| Sensation in the Peroneal Nerve Distribution | Number of participants with self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block) | Upon emergence from anesthesia in the PACU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infiltration between popliteal artery and capsule of knee (iPACK)