Evaluation of a Fast-track Knee Arthroplasty Concept

Study Overview
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Brief Summary
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Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

Detailed Description
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Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

Official Title
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Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial

Conditions
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Knee Arthropathy, Postoperative Pain, Postoperative Complications

Intervention / Treatment
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* Procedure: local infiltration analgesia
* Procedure: regional-anaesthesiological catheter analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective, primary knee joint replacement in combined general anaesthesia Exclusion Criteria: heart insufficiency NYHA >2 liver insufficiency > CHILD B evidence of diabetic polyneuropathy severe adipositas BMI >40 patients < 18 years pregnancy in case of police custody participation in a paralleled interventional RCT in a time frame of 30 days chronic opioid therapy >3 months before scheduled surgery allergy against medication required for surgery or anaesthesia

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local infiltration analgesia<br>Patient receive an infiltration of local anaesthetics around the knee to achieve maximal distal block of nerve fibres. Infiltration is performed directly after knee replacement and during weaning of general anaesthesia. | Procedure: local infiltration analgesia<br>* Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.<br>* Other names: LIA technique;|
| Active Comparator: Regional anaesthesia<br>Patients receive a combined anaesthesia with a regional-anaesthesiological catheter placed close to the distal Nervus saphenus and a single shot anaesthesia of Nervus ischiadicus using local anaesthetics (regional-anaesthesiological catheter analgesia). | Procedure: regional-anaesthesiological catheter analgesia<br>* Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first mobilisation (standing) | time from end of surgery until patients is able to stand | up to 48h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction (11-point likert scale) | global satisfaction of patients | up to 7 days postoperatively | 
| time to first mobilisation (walking) | time from end of surgery until patients is able to walk | up to 7 days postoperatively | 
| complications | complications during perioperative care process (e.g. thrombosis, re-operation, infection) | up to 7 days postoperatively | 
| time to achieve full joint mobility | time to achieve full joint mobility (0/0/90°) | up to 7 days postoperatively | 
| pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean) | mean pain intensity of patients | up to 7 days postoperatively | 
| rescue pain medication | number of patients requiring rescue pain medication | up to 7 days postoperatively | 
| pain medication perioperatively | pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics) | up to 7 days postoperatively | 
| time to discharge | time to discharge from hospital | up to 14 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia