Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine

Study Overview
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Brief Summary
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Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.

Detailed Description
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Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.

Official Title
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Dexmedetomidine as Adjunct Medication to Local Infiltration Anesthesia (LIA) vs Ultrasound-Guided Regional Anesthesia (USRA) in Regard to Patients' Need for Opioids, Wellbeing, Satisfaction, and Knee Functionality in Knee-endoprosthetics

Conditions
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Pain, Postoperative, Anesthesia, Local, Gonarthrosis

Intervention / Treatment
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* Drug: Ultrasound guided regional anesthesia
* Drug: Local infiltration analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult non pregnant patients with gonarthrosis who have given written consent for participation Exclusion Criteria: Age below 18 years pregnancy breast-feeding patients allergies against study medication missing or denied written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Ultrasound guided regional anesthesia<br>Patient will be given a peripheral nerve block from their treating anesthesiologist before the operation (in the OR) with an conventional ultrasound guided femoral and sciatic block of each 15 ml ropivacaine 0,5% and 0,5 ml dexmedetomidine (100µg/ml). | Drug: Ultrasound guided regional anesthesia<br>* Applied perineurally preoperatively ultrasound guided regional anesthesia<br>* Other names: Ropivacaine;|
| Active Comparator: Local infiltration analgesia<br>Patient will be given a local infiltration analgesia from their treating surgeon during the operation (in the OR) with 60 ml ropivacaine 0,5% and 1 ml dexmedetomidine (100µg/ml). | Drug: Local infiltration analgesia<br>* Applied in the wound intraoperatively from the orthopedics<br>* Other names: Ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of opioid consumption in oral morphine equivalent | consumed opioids in mg of oral morphine equivalent | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assesment | Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome) | 5 days postoperatively or until discharge | 
| Pain medication necessary | Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day | 5 days postoperatively or until discharge | 
| Functionality of the prothesis - OKS (Oxford Knee Score) | According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome) | 5 days postoperatively or until discharge | 
| Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score) | According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome) | 5 days postoperatively or until discharge | 
| Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) | According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome) | 5 days postoperatively or until discharge | 
| Functionality of the prothesis- G-FJS (German Forgotten Joint Score) | According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome) | 5 days postoperatively or until discharge | 
| Complications | Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation) | 5 days postoperatively or until discharge | 
| procedure specific time | time of the operation | during surgery |