Comparative Analysis of the Effectiveness and Safety of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block in the Anesthesia Complex for Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Total dose of opioid analgesics
研究概览
简要总结
Total hip replacement is one of the most common orthopedic operations. According to statistical studies, more than 1 million of such surgical interventions are performed annually in the world. The average age of primary hip replacement surgery is 69 y.o.
Modern approaches of control of general anesthesia allow safe performance of different surgical interventions under general anesthesia. However, general anesthesia does not have an effective and long-lasting effect on relieving operational stress compared to neuraxial anesthesia. To achieve a similar effect, it is necessary to adhere to the principle of multimodality of anesthesia, and the most promising method is a combination of general and regional anesthesia. peripheral blocks are described in the literature, aimed at analgesia directly in the hip joint area, and effectively used in orthopedics.
Most blocks are currently performed under ultrasound control, the risk of nerve damage and accidental intravascular administration of local anesthetics is potentially reduced. It was established that the use of ultrasound guidance reduces the number of attempts and the amount of anesthetic administered, as well as reduces the time required to perform a block.
Another predicted effect is a reduction in the doses of opioids and non-steroidal anti-inflammatory drugs (NSAIDs), which can cause gastrointestinal bleeding and have a nephrotoxic effect, and can also depress breathing. It should be noted that patients over 65 y.o., have the highest risks of these side effects.
This study aims to compare the effectiveness and safety of SFIB and PENG block in hip replacement, as well as evaluation of the effectiveness of combined anesthesia in comparison with general anesthesia without the use of peripheral blocks.
详细描述
Patients will be randomized into three groups group:
Group 1: General anesthesia with SFIB
In this group, under the ultrasound control, a local anesthetic will be injected into the interfacial space of the iliac muscle, in the area of the passage of the deep artery that surrounds the ilium. The block will be performed over the inguinal fold medial to the upper anterior iliac spine. After ultrasound identification of the needle's location in the interfacial space, 40 ml of a 0.5% solution of Ropivacaine will be administered.
Group 2: General anesthesia with PENG block
The block is performed using ultrasound navigation. After identifying the ileo-lumbar tendon, 40 ml of 0.5% Ropivacaine solution is injected under it. Ropivacaine spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed, dated informed consent form
- •Age from 50 to 75 years
- •Indications for primary total hip replacement
- •American Society of Anesthesiologists (ASA) score from 1 to 3
排除标准
- •Patients receiving beta blockers;
- •Infectious manifestations at the puncture site;
- •Bleeding, clinically significant hypovolemia of any origin, shock;
- •Disorders of the blood coagulation system;
- •Intolerance to local anesthetics;
- •Demyelinating diseases of the nervous system;
- •Allergy to local anesthetics;
- •Psychiatric diseases;
- •Any conditions that prevent obtaining informed consent.
结局指标
主要结局
Total dose of opioid analgesics
时间窗: 24 hours after surgery
The total amount of consumed fentanyl required for pain relief will be recorded 24 hours after surgery. For this purpose number of fentanyl boluses will be multiplied on dose size for each included patient.
次要结局
未报告次要终点