The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.

Official Title
-----------------
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

Conditions
-----------------
Postoperative Pain, Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Adductor-Canal-Blockade with Ropivacaine
* Procedure: Adductor-Canal-blockade with saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total Knee Arthroplasty in general anaesthesia ASA 1-3 BMI 18-40 Written informed consent Exclusion Criteria: Can not cooperate to the exam Do not speak or understand Danish Drug allergy Alcohol or drug abuse Daily consumption of strong opioids

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: Adductor-Canal-Blockade with Ropivacaine<br> | Procedure: Adductor-Canal-Blockade with Ropivacaine<br>* US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml<br>* Other names: US-guided nerve block;|
| Placebo Comparator: Adductor-Canal-blockade with saline<br> | Procedure: Adductor-Canal-blockade with saline<br>* US-guided Adductor-Canal-blockade with saline<br>* Other names: Sham block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during 45 degrees active flexion of the knee | 0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative | 1 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during 45 degrees active flexion of the knee | 0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the area under the curve (AUC) for the interval 1-6 hours postoperative. | 0-6 hours postoperative | 
| Pain during rest | 0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the area under the curve (AUC) for the interval 1-6 hours postoperative. | 1-6 hours postoperative | 
| A change in pain score in the ropivacaine group, after activating the block | 0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block. | 30-60 minutes postoperative | 
| Total morphine consumption | Total morphine consumption at the interval 30 minutes - 6 hours postoperative. | 30 minutes - 6 hours postoperative | 
| Postoperative nausea | Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative. | 1-6 hours postoperative | 
| Postoperative vomiting | Number of vomiting episodes at the interval 1-6 hours postoperative. | 1-6 hours postoperative | 
| Zofran consumption | Total zofran consumption at the intervals 1-6 hours postoperative. | 1-6 hours postoperative | 
| Sedation | Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative. | 1-6 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, total knee arthroplasty