Optimization of a Fast-track Concept for Knee Joint Replacement

Study Overview
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Brief Summary
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In an estimated 150,000 patients, a knee joint replacement is performed in Germany every year. The perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. Patients experience pain especially intraoperatively and in the first days after the operation. The intensity of pain is a decisive factor that can hinder the patient's mobilization. In the KneeOptOut study (ethics application number EA4/009/17), which has already been successfully carried out and approved by this ethics committee, it was shown that the use of local infiltration anaesthesia (LIA) for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia (manuscript under review at the European Journal of Anaesthesiology). During surgery, the morphine requirement of patients in the LIA group was significantly higher than that of patients who underwent catheterization. Postoperatively, however, both subjective pain by VAS and opiate consumption were comparable. In order to optimize the intraoperative opiate need/consumption, an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure. Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeon's requirements.

Official Title
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Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial

Conditions
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Knee Arthropathy, Postoperative Pain, Postoperative Complications

Intervention / Treatment
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* Procedure: Late local infiltration analgesia
* Procedure: Early local infiltration 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early-intraoperative Local infiltration technique<br>A distal regional anaesthesia is performed in which the nerves are blocked by a local anaesthetic in the tissue in the immediate vicinity of the operating area (tissue infiltration technique). The LIA is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached. | Procedure: Early local infiltration analgesia<br>* The local infiltration analgesia is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached.<br>* Other names: early LIA;|
| Active Comparator: Late-intraoperative Local infiltration technique<br>A distal regional anaesthesia is performed in which the nerves are blocked by a local anaesthetic in the tissue in the immediate vicinity of the operating area (tissue infiltration technique). The LIA is applied after the preparation of the femur and tibia bone shortly before the prosthesis is inserted and during the retreat from the knee joint. | Procedure: Late 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: late LIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | amount of opioids administered intraoperative measured as equivalent dose to morphin | intraoperative, up to 3 hours | 

Secondary 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 48 hours postoperatively | 
| 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 | 
| time to achieve full joint mobility | time to achieve full joint mobility (0/0/90°) | up to 7 days postoperatively | 
| Janda grade of both legs at first day after surgery | best Janda grade in both legs the day after surgery | up to 24h postoperatively | 
| Pain intensity | intensity of pain in all patients meausered by numeric rating scale (NRS) | up to 7 days postoperatively | 
| rescue pain medication | number of patients requiring rescue pain medication | up to 7 days postoperatively | 
| time to discharge | time to discharge from hospital | up to 14 days postoperatively | 
| Opioid consumption (hospital) | amount of opioids administered until discharge measured as equivalent dose to morphin | up to 14 days postoperatively | 
| delirium | incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc) | up to 7 days postoperatively | 
| postoperative nausea and vomiting (PONV) | incidence of PONV | up to 7 days postoperatively | 
| surgeon satisfaction (6-point likert scale) | satisfaction of surgeon in points of clarity of the operative field, change of the operative field by LIA and overall satisfaction represented in one value | intraoperative, up to 3 hours | 

 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