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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
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.
Charité - Universitätsmedizin Berlin
Berlin, Germany
Opioid consumption
amount of opioids administered intraoperative measured as equivalent dose to morphin
Time frame: intraoperative, up to 3 hours
time to first mobilisation (standing)
time from end of surgery until patients is able to stand
Time frame: up to 48 hours postoperatively
patients satisfaction (11-point likert scale)
global satisfaction of patients
Time frame: up to 7 days postoperatively
time to first mobilisation (walking)
time from end of surgery until patients is able to walk
Time frame: up to 7 days postoperatively
time to achieve full joint mobility
time to achieve full joint mobility (0/0/90°)
Time frame: 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
Time frame: up to 24h postoperatively
Pain intensity
intensity of pain in all patients meausered by numeric rating scale (NRS)
Time frame: up to 7 days postoperatively
rescue pain medication
number of patients requiring rescue pain medication
Time frame: up to 7 days postoperatively
time to discharge
time to discharge from hospital
Time frame: up to 14 days postoperatively
Opioid consumption (hospital)
amount of opioids administered until discharge measured as equivalent dose to morphin
Time frame: up to 14 days postoperatively
delirium
incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)
Time frame: up to 7 days postoperatively
postoperative nausea and vomiting (PONV)
incidence of PONV
Time frame: 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
Time frame: intraoperative, up to 3 hours
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