Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to: Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Detailed Description
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Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to: Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Official Title
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Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: ropivacaine
* Drug: adrenaline
* Drug: ketorolac
* Drug: morphine
* Drug: fentanyl
* Drug: bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients at least 18 years of age scheduled for elective total knee arthroplasty ASA I-III signed written informed consent Exclusion Criteria: age < 18 ASA > III moderate or severe cardiac disease, bronchial asthma allergy against ropivacaine, ketorolac or morphine analgetic abuse pregnancy or nursing women severe psychiatric disease moderate to severe dementia

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIA IV<br>Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine | Drug: ropivacaine<br>* intraoperative and 1. postoperative day<br>* Other names: Naropin;Drug: adrenaline<br>* intraoperative LIA (IV and IA) and continuous EDA<br>* Other names: (epinephrine);Drug: ketorolac<br>* intraoperative and 1. postoperative day<br>* Other names: Toradol;Drug: morphine<br>* intraoperative<br>* Other names: Morfin;|
| Experimental: LIA IA<br>Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine | Drug: ropivacaine<br>* intraoperative and 1. postoperative day<br>* Other names: Naropin;Drug: adrenaline<br>* intraoperative LIA (IV and IA) and continuous EDA<br>* Other names: (epinephrine);Drug: ketorolac<br>* intraoperative and 1. postoperative day<br>* Other names: Toradol;Drug: morphine<br>* intraoperative<br>* Other names: Morfin;|
| Active Comparator: EDA<br>standard continuous epidural analgesia | Drug: adrenaline<br>* intraoperative LIA (IV and IA) and continuous EDA<br>* Other names: (epinephrine);Drug: fentanyl<br>* continuous postoperatively<br>Drug: bupivacaine<br>* continuous postoperatively<br>* Other names: Marcain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Rest (VAS) | VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain. | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses. | 48 hours postoperative | 
| Time to Readiness for Discharge | Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs. | up to 10 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee arthroplasty, local infiltration analgesia, TKA, epidural analgesia, operation, surgery