Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective, primary knee joint replacement in combined general anaesthesia
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Early local infiltration analgesia (Procedure)
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.
干预措施: Late local infiltration analgesia (Procedure)
结局指标
主要结局
Opioid consumption
时间窗: intraoperative, up to 3 hours
amount of opioids administered intraoperative measured as equivalent dose to morphin
次要结局
- time to first mobilisation (standing)(up to 48 hours postoperatively)
- 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)
- 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)
研究者
Sascha Treskatsch
Prof. Dr. med., Head of Department
Charite University, Berlin, Germany