Ultrasound-guided Genicular Nerve Block: An Analgesic Alternative to LIA for Total Knee Arthroplasty.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- NRS at PACU
研究概览
简要总结
The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia (LIA). It is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee, reducing the total dose of local anesthetic and adrenaline very markedly.
详细描述
The main objective is to demonstrate that the ultrasound-guided geniculate nerve block provides not-inferior analgesia to LIA in patients undergoing primary total knee arthroplasty (TKA) in the first 24 hours postoperatively, and during the first mobilization using the numerical evaluation of the pain (NRS).
The secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive LIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for primary elective total knee arthroplasty
- •American Society of Anesthesiologists Physical Status I-III
- •BMI 18-40 kg/m2
排除标准
- •Inability to cooperate with protocol
- •Allergy to any medication of protocol
- •Contraindication to peripheral nerve block (e.g. local or systemic infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
- •Revision or prothesis replacement knee surgery
- •Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
- •Bleeding diathesis or non-pharmacological coagulopathy
结局指标
主要结局
NRS at PACU
时间窗: 1 hour after surgery
NRS \[Numerical Rating Scale, 0-11\] at PACU \[post-anaesthesia care unit\] after spinal block reversal, evaluated as active contralateral knee genuflection at 90 degrees.
NRS at 12 hours after surgery
时间窗: 12 hours
Pain will be assessed by NRS \[Numerical Rating Scale, 0-11\] by a ward nurse, blind for intraoperative analgesic treatment.
NRS at 24 hours after surgery
时间窗: 24 hours
Pain will be assessed by NRS \[Numerical Rating Scale, 0-11\] by a ward nurse, blind for intraoperative analgesic treatment.
NRS after physiotherapy
时间窗: 24 hours
It corresponds to day 1 after the surgical intervention and will be carried out in the hospitalization room by a physiotherapist. The NRS \[Numerical Rating Scale, 0-11\] will be recorded during the first examination and mobilization
次要结局
- Opioid consumption in the postoperative period(until 24 hours)
- Quality of sleep(24 hours)
- Knee mobility range(24 hours)
研究者
TOMAS MIGUEL CUÑAT LOPEZ
Principal Investigator
Hospital Clinic of Barcelona