Optimization of a Fast-track Concept for Knee Joint Replacement (KneeOptOut2)
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|ClinicalTrials.gov Identifier: NCT03920930|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : July 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Arthropathy Postoperative Pain Postoperative Complications||Procedure: Late local infiltration analgesia Procedure: Early local infiltration analgesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either early or late local infiltration technique perioperatively. Patients will be blinded against early or late local infiltration technique. Blinding of the treating physician will not be possible.|
|Official Title:||Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: Early-intraoperative Local infiltration technique
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
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.
Other Name: early LIA
Active Comparator: Late-intraoperative Local infiltration technique
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
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
Other Name: late LIA
- Opioid consumption [ Time Frame: intraoperative, up to 3 hours ]amount of opioids administered intraoperative measured as equivalent dose to morphin
- time to first mobilisation (standing) [ Time Frame: up to 48 hours postoperatively ]time from end of surgery until patients is able to stand
- patients satisfaction (11-point likert scale) [ Time Frame: up to 7 days postoperatively ]global satisfaction of patients
- time to first mobilisation (walking) [ Time Frame: up to 7 days postoperatively ]time from end of surgery until patients is able to walk
- time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]time to achieve full joint mobility (0/0/90°)
- Janda grade of both legs at first day after surgery [ Time Frame: up to 24h postoperatively ]best Janda grade in both legs the day after surgery
- Pain intensity [ Time Frame: up to 7 days postoperatively ]intensity of pain in all patients meausered by numeric rating scale (NRS)
- rescue pain medication [ Time Frame: up to 7 days postoperatively ]number of patients requiring rescue pain medication
- time to discharge [ Time Frame: up to 14 days postoperatively ]time to discharge from hospital
- Opioid consumption (hospital) [ Time Frame: up to 14 days postoperatively ]amount of opioids administered until discharge measured as equivalent dose to morphin
- delirium [ Time Frame: up to 7 days postoperatively ]incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)
- postoperative nausea and vomiting (PONV) [ Time Frame: up to 7 days postoperatively ]incidence of PONV
- surgeon satisfaction (6-point likert scale) [ Time Frame: intraoperative, up to 3 hours ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920930
|Contact: Sascha Treskatsch, MD, Profemail@example.com|
|Charité - Universitätsmedizin Berlin||Recruiting|
|Berlin, Germany, 10117|
|Contact: Sascha Treskatsch, MD, Prof 004930450631 ext 011 firstname.lastname@example.org|
|Sub-Investigator: Martin Ertmer, MD|
|Sub-Investigator: Ralf F Trauzeddel, MD|