Analgesic Efficacy of PENG Block Compared to FIB Block in the Elderly Patient With Fracture of the Proximal Femur in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of success rate of PENG block (defined as NRS score </ = 4 at 30 minutes from the blockade placement by comparing it to the analgesic effect of the FIB block, also evaluated at 30 minutes as NRS score </ = 4).
研究概览
简要总结
The trial aims to verify a possible greater analgesic efficacy of PENG (Pericapsular Nerve Group) block compared to iliac fascia block (FIB block) in elderly patients (age > 65 years) suffering from traumatic fracture of proximal femur in emergency room.
详细描述
Prospective randomized double-blind single-center preliminary study aimed to demonstrate a possible greater analgesic efficacy of the PENG block compared to the iliac fascia block (FIB block) in elderly patients (age > 65 years) suffering from traumatic fracture of the proximal femur in emergency room.
The study will cover patients aged > 65 years suffering from a proximal traumatic fracture of the femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Roma 1).
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 105 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients > 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of Regional Health System (Regione Lazio).
排除标准
- •Failure to acquire written and valid informed consent
- •Obesity (BMI> 35 kg / m2)
- •Contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics)
- •Patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, NSAIDs, acetaminophen for chronic painful conditions;
- •History of alcohol or drug abuse;
- •Severe kidney or liver failure;
- •Cognitive alterations, dementia, psychiatric pathologies
结局指标
主要结局
Evaluation of success rate of PENG block (defined as NRS score </ = 4 at 30 minutes from the blockade placement by comparing it to the analgesic effect of the FIB block, also evaluated at 30 minutes as NRS score </ = 4).
时间窗: 30 minutes after the placement of nerve block
Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain).
次要结局
- Evaluation of rest and incident pain(30 minutes after the placement of nerve block)
- Check for any complications related to analgesic (PENG and FIB) blocks(from 30 minutes to 12 hours)
- Onset time and duration of nerve blockade(from 30 minutes to 12 hours)
- Use of rescue-medication in pain treatment(from 30 minutes to 12 hours)
研究者
Dr Francesco Marrone
Principal Investigator
Santo Spirito Hospital, Italy