Dexmedetomidine as Adjunct Medication to Local Infiltration Anesthesia (LIA) vs Ultrasound-Guided Regional Anesthesia (USRA) in Regard to Patients' Need for Opioids, Wellbeing, Satisfaction, and Knee Functionality in Knee-endoprosthetics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Need of opioid consumption in oral morphine equivalent
研究概览
简要总结
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.
详细描述
Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non pregnant
- •patients with gonarthrosis who have given written consent for participation
排除标准
- •Age below 18 years
- •pregnancy
- •breast-feeding patients
- •allergies against study medication
- •missing or denied written consent
研究组 & 干预措施
Ultrasound guided regional anesthesia
Patient will be given a peripheral nerve block from their treating anesthesiologist before the operation (in the OR) with an conventional ultrasound guided femoral and sciatic block of each 15 ml ropivacaine 0,5% and 0,5 ml dexmedetomidine (100µg/ml).
干预措施: Ultrasound guided regional anesthesia (Drug)
Local infiltration analgesia
Patient will be given a local infiltration analgesia from their treating surgeon during the operation (in the OR) with 60 ml ropivacaine 0,5% and 1 ml dexmedetomidine (100µg/ml).
干预措施: Local infiltration analgesia (Drug)
结局指标
主要结局
Need of opioid consumption in oral morphine equivalent
时间窗: 48 hours postoperatively
consumed opioids in mg of oral morphine equivalent
次要结局
- Pain assesment(5 days postoperatively or until discharge)
- Pain medication necessary(5 days postoperatively or until discharge)
- Functionality of the prothesis - OKS (Oxford Knee Score)(5 days postoperatively or until discharge)
- Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score)(5 days postoperatively or until discharge)
- Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)(5 days postoperatively or until discharge)
- Functionality of the prothesis- G-FJS (German Forgotten Joint Score)(5 days postoperatively or until discharge)
- Complications(5 days postoperatively or until discharge)
- procedure specific time(during surgery)