Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain After TKA

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe pain (VAS pain score > 60) after Total Knee Arthroplasty (TKA.

Detailed Description
-----------------
The patients will be included after surgery (the first 2 postoperative days). Patients reporting VAS > 60 during active flexion of the knee can be included. All included patients will receive 2 blockades at the same time - an ACB and a FNB, one blockade with 30ml ropivacaine 0,2% and the other with 30ml saline according to randomization. Prior to, and after, the blockades VAS pain scores will be obtained, muscle strength (quadriceps and adductors) will be measured using a handheld dynanometer and a Timed Up and Go test will be performed. The study is registered at clinicaltrials.gov after inclusion of the first patient. The reason for this is that we recently became aware of that some journals do not accept a EudraCT registration. The study was registered at EudraCT (2012-004554-28)prior to enrollment of patients.

Official Title
-----------------
Effect of Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain in Patients With Severe Pain After Total Knee Arthroplasty

Conditions
-----------------
Mobility After Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TKA within 72 hours and VAS>60 during 45 degrees active flexion of the knee despite conventional pain medication informed consent ASA 1-3 BMI 18-40 Exclusion Criteria: Unable to communicate in Danish Allergic reactions toward ropivacaine Alcohol and or drug abuse Unable to cooperate Known sensory disturbances in the lower limbs

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active FNB, placebo ACB<br>FNB with 30 ml of ropivacaine 0,2% and ACB with 30 ml of placebo (saline). The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0. | Drug: Ropivacaine<br> <br> * Other names: Naropin;Drug: Placebo<br> <br> * Other names: Saline;|
| Experimental: Active ACB, placebo FNB<br>ACB with 30 ml of ropivacaine 0,2% and FNB with 30 ml of placebo (saline.The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0. | Drug: Ropivacaine<br> <br> * Other names: Naropin;Drug: Placebo<br> <br> * Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change i muscle strength of the quadriceps muscle, after the blockade | Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle will be measured before and 2 hours after the blockade. The change will be compared between the groups. At each measuring point three measurements will be made and the average of these used. | 0 and 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength, adductor muscles | MVIC of the adductors will be measured before and 2 hours after the blockades. The change will be compared between the groups. At each measuring point three measurements will be made and the average of these used. | 0 and 120 minutes | 
| Timed Up and Go (TUG)test | The change in time to perform a TUG test before and after the blockades will be compared between the groups. Also the change in highest pain score during the TUG tests will be compared between the groups | 0 and 120 minutes | 
| VAS pain scores at rest | VAS pain scores at rest will be obtained before VAS pain scores during passive flexion of the knee. The change between groups will be compared | 0 and 120 minutes | 
| Pain during passive flexion of the knee | VAS pain scores during passive 45 degrees flexion of the knee. The change will be compared between the groups. VAS during passive flexion will be obtained prior to the MVIC measurements and the TUG test | 0 and 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Arthroplasty, Adductor Canal Blockade, Us-guided nerve blockade