Femoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty

Study Overview
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Brief Summary
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The objective of this trial is to compare the efficacy of three different nerve blocks as an analgesic option after total knee arthroplasty (TKA), based on muscle strength, mobilization and pain. The Adductor Canal Block has been proposed as an equally effective technique to the Femoral Nerve Block in terms of pain control after a TKA, with the benefit of preserving muscle function. We hypothesize that a block performed at the apex of the femoral triangle would best balance analgesia with quadriceps function.

Official Title
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Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty, a Prospective Comparative Study: Adductor Canal Block vs. Femoral Nerve Block vs. Apex Femoral Triangle Block

Conditions
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Arthroplasty, Replacement, Knee, Anesthesia, Conduction, Pain, Postoperative, Ultrasonography, Interventional

Intervention / Treatment
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* Procedure: Apex Femoral Triangle Block
* Procedure: Femoral Nerve Block
* Procedure: Adductor Canal Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of any gender, from 18 to 90 years old that accept to participate in the study. Programmed primary total knee arthroplasty surgery Exclusion Criteria: Emergent surgery Reinterventions Unstable psychiatric pathology, dementia Kidney or hepatic disease that contraindicates the use of NSAIDs and/or Paracetamol. Allergy to amides local anesthesics, NSAIDs, opioids and/or Paracetamol. Daily use of opioids greater than 30 mg of morphine (or equivalent) Patients under 18 or over 90 years old. Drug abuse Rejection to be a participant of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral Nerve Block<br>Ultrasound guided femoral nerve block, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered. | Procedure: Femoral Nerve Block<br>* Regional anesthetic technique that blocks the sensory and motor information of the femoral nerve (and it's branches).<br>|
| Active Comparator: Adductor Canal Block<br>Ultrasound guided adductor canal block, at the proximal third of the canal, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered. | Procedure: Adductor Canal Block<br>* Interfascial block that targets mainly the saphenous nerve.<br>|
| Experimental: Apex Femoral Triangle Block<br>Ultrasound guided femoral triangle block, at the distal third of the triangle, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered. | Procedure: Apex Femoral Triangle Block<br>* Nerve block that aims the vastus medialis nerve, the saphenous nerve and the anterior femoral cutaneous nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum voluntary isometric contraction (MVIC) | It measures quadriceps strength and is normalized to the body mass index (N * m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to reach maximum force and hold for three seconds. Three measurements will be done, and the average will be taken. The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6 hours postoperatively. A higher the percentage will relate with less motor block. | 6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) | Timed Up and Go gauges a patient's sense of balance by measuring the time required for a certain set of movements: stand up from a chair, walk 3 m, walk back, and sit down. It has been verified to serve as a good indicator of functional level. Measured in seconds, the better values are related to shorter times. | 6, 24 and 48 hours postoperatively. | 
| 30' CST (30 secs Chair Stand Test) | How many times can a patient stand up and sit down from a chair in 30 seconds. The amount of times will be counted, more times will be related to a better outcome. | 6, 24 and 48 hours postoperatively. | 
| Range of Motion (ROM) | Range of motion refers to a knee's degree of extension or flexion and is measured via a goniometer. Considering normal values from 0-120º, the baseline movement will be measured preoperatively to be compared postoperatively. | 6, 24 and 48 hours postoperatively. | 
| Daniels' Test | Active extension of the knee against gravity and applied resistance (0-5). 5: normal contraction against gravity and maximal resistance. 0: abscence of contraction. | 6, 24 and 48 hours postoperatively. | 
| 10-PMS (10 point Mobility Scale) | Scale from 0-10 in which the mobility of the patient is measured; sitting on the bed, chair, edge of the bed, mobilize the knee more than 45º, stand up, walk with or without a mobility aid. Higher values are related to better outcomes. An expected degree of flexion of the knee is ≥45 degrees on postoperative day 1 and ≥70 degrees on postoperative day 3. Expected points for postoperative day 0: 4 points Expected points for postoperative day 1: 8 points Expected points for postoperative day 2: 9-10 points | 6, 24 and 48 hours postoperatively. | 
| Pain measurement trough the visual analogue scale (VAS) | Pain will be measured via the VAS pain score by having the patient point on an unmarked scale how their pain was and then translating it to millimeters on the 100-mm scale. 0 mm: no pain 100 mm: severe/extreme pain | 6, 24 and 48 hours postoperatively. | 
| Quantity of opioids administered | into morphine equivalent if needed. | 6, 24 and 48 hours postoperatively. | 
| APS-POQ-R. | Developed by an interdisciplinary task force of members of the American Pain Society, the Patient Outcome Questionnaire (APS-POQ) for QI has been revised to include instrument psychometrics. The article is available by open access at The Journal of Pain web site. | At 24 hours postoperatively | 
| Patient satisfaction | Scale from 0 to 10, answering how do they feel about the treatment received, being 10 the maximum value related to the highest satisfaction level. | 24 and 48 hours postoperatively | 
| Length of hospital stay | Days from surgery until discharge. | at patient discharge, an average of 6 days postoperatively | 
| Maximum voluntary isometric contraction (MVIC) | It measures quadriceps strength and is normalized to the body mass index (N * m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to reach maximum force and hold for three seconds. Three measurements will be done, and the average will be taken. The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6, 24, and 48 hours postoperatively. A higher the percentage will relate with less motor block. | 24 and 48 hours postoperatively. |