Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Arthropathy
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Opioid consumption
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Sascha Treskatsch
Prof. Dr. med., Head of Department
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
Opioid consumption
Time Frame: intraoperative, up to 3 hours
amount of opioids administered intraoperative measured as equivalent dose to morphin
Secondary Outcomes
- time to first mobilisation (walking)(up to 7 days postoperatively)
- Opioid consumption (hospital)(up to 14 days postoperatively)
- patients satisfaction (11-point likert scale)(up to 7 days postoperatively)
- time to first mobilisation (standing)(up to 48 hours postoperatively)
- Janda grade of both legs at first day after surgery(up to 24h postoperatively)
- Pain intensity(up to 7 days postoperatively)
- time to discharge(up to 14 days postoperatively)
- surgeon satisfaction (6-point likert scale)(intraoperative, up to 3 hours)
- rescue pain medication(up to 7 days postoperatively)
- delirium(up to 7 days postoperatively)
- time to achieve full joint mobility(up to 7 days postoperatively)
- postoperative nausea and vomiting (PONV)(up to 7 days postoperatively)