A Prospective, Randomized, Double-blind, Multicenter Trial on the Effects of the Early Femoral Nerve Block in Elderly With Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
Assess if the addition of an early femoral nerve block (performed within 2 hours from the admission in emergency department through a femoral nerve catheter) in the elderly patients (> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by CAM 3Ds test, compared to the traditional systemic pain therapy.
详细描述
In the Emergency Department (ED) all the patients with a diagnosis of femoral neck fracture that have completed the instrumental tests, will receive 0,5 mL/kg/h infusion of physiologic solution started through an indwelling IV catheter sited in the forearm at the opposite side of the fracture.
Afterwards the orthopedic surgeon will assess whether the patient can be part of the study, and after having explained to the patient the study and obtaining written informed consent from each individual he will call the anesthesiologist to perform the cognitive tests. The questionnaires will be short test lasting a few minutes (5 to 10 min): the Mini Cog Test and the Confusion Assessment Method (CAM 3D S) run in its shortened form (14).
This questionnaire, validated for the early detection of mental status changes, can be filled by the operator based on the answers provided by the patient during the execution of the Mini Cog test. If the tests did not highlight any cognitive impairment, the anesthesiologist will proceed to the placement of a femoral nerve catheter with the ultrasound-guided technique.
The catheters will be placed using direct US visualization. A hyperechoic needle will be inserted (e-cath 51x83mm, Pajunk®, Germany) at the inguinal ligament lateral to the artery. The needle is advanced until the tip is adjacent to the nerve inside the fascia. Then, 5 mL of saline solution is injected to make the advancement of the catheter easier. The catheter will be placed medially to the nerve and secured by taping it to the skin using its own kit. The catheter will be used for postoperative analgesia in all patients.
After that, using a computer-generated of random sequence number, the patients will be divided in two groups in a randomized manner as follow:
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)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >70 years with femoral neck fracture, and admission in ED from Monday to Friday (from 8.00 am to 20.00 pm)
- •American society of anesthesiologists (ASA) Physical status classification I-III
- •Signed informed consent
排除标准
- •Contraindications to the regional anesthesia
- •Patients allergic to one or more drugs used in the study
- •Patients who are unable or refuse to provide informed consent
- •Patients who show a cognitive impairment or signs of confusion or delirium already on arrival in ED
- •Patients with access to ED Outside the times set in the inclusion criteria
- •Postoperative ICU admission
- •Patients with Hb < 8 mg/dl at admission
研究组 & 干预措施
femoral group
Group 1: placement of a femoral nerve catheter plus femoral block with 15 ml of a Ropivacaine 0,75% solution through the femoral catheter
干预措施: femoral nerve catheter (Procedure)
femoral group
Group 1: placement of a femoral nerve catheter plus femoral block with 15 ml of a Ropivacaine 0,75% solution through the femoral catheter
干预措施: femoral group (Drug)
control group
Group 2: placement of a femoral nerve catheter plus the administration of an equivalent volume (15 ml) of a saline solution through the femoral catheter
干预措施: femoral nerve catheter (Procedure)
control group
Group 2: placement of a femoral nerve catheter plus the administration of an equivalent volume (15 ml) of a saline solution through the femoral catheter
干预措施: control group (Drug)
结局指标
主要结局
Incidence of delirium
时间窗: From hospital admission to home discharge, an average of 14 days
Assess if the addition of an early femoral nerve block (performed within 2 hours from the admission in emergency department) in the elderly patients (\> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by CAM 3Ds test, compared to the traditional systemic pain therapy.
次要结局
- Mortality at 1,3,12 months after surgery(1,3,12 months postoperative)
- Perioperative pain(From hospital admission to home discharge, an average of 14 days)
- Length of hospital stay (LOS)(From hospital admission to home discharge, an average of 14 days)
- Postoperative complications(From hospital admission to home discharge, an average of 14 days)
研究者
Gianluca Cappelleri
MD
ASST Gaetano Pini-CTO