Comparison of Two Different Approaches in the Fascia Iliaca Compartment Block in Femoral Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Morphine Consumption
研究概览
简要总结
Fascia Iliaca Compartment Block (FICB) is a popular regional anaesthetic technique for surgical procedures involving the hip joint and femur. The FICB may be thought of as an anterior approach to the lumbar plexus where local anaesthetic is injected proximally beneath the fascia iliaca, with the aim of blocking the femoral nerve ,obturator nerve and lateral cutaneous nerve of thigh simultaneously.
In addition to providing effective analgesia, peripheral nerve blocks are increasingly preferred especially in frail patient groups such as the geriatric population which femoral fractures are the most common, because of their advantages such as avoiding the complications of neuraxial anesthesia and the side effects of opioids.
FICB can be applied with ultrasound-guided suprainguinal or infrainguinal approaches. Studies on the superiority of the two methods used in clinical practice are limited. In this study, it is aimed to compare the suprainguinal (Group S) and infrainguinal (Group I) approaches of FICB applied in the preoperative period in femoral fractures in which spinal anesthesia method was chosen. These two methods will be compared in terms of postoperative pain scores (11-point numeric scale), morphine consumption (by intravenous patient controlled analgesia for postoperative 24 hours) and possible side effects-complications.
详细描述
After ethical committee approval, at least 68 patients who will undergo surgery for femoral fracture will be included in the study. Our study was planned as prospective, randomized, double-blind.
At least 68 patients of both sexes, 18 years of age and older, American Society of Anesthesiologists Score-1,2,3 ( ASA 1,2,3) who will undergo surgery for femoral fracture will be included.
Patients who will undergo surgery will be divided into two randomized groups, each containing 34 patients, in the preoperative unit with a randomization program, as the group in which FICB was applied with the suprainguinal approach (Group S) and the group in which FICB was applied with the infrainguinal approach (Group I).
Routine monitoring [electrocardiogram (ECG), noninNRSive blood pressure, peripheral oxygen saturation (SpO2) measured by pulse oximetry] will be performed for both groups, and heart rate (beats/minute), blood pressure (mmHg), SpO2 (%) will be recorded. Pain intensity, as measured by the 11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be recorded. All patients in both groups will be administered a mixture of 200mg 2% lidocaine and 0.25% 75mg bupivacaine, with a total volume of 40 ml, with an 80 mm peripheral block needle, accompanied by ultrasonography (US). To avoid toxic doses of local anesthetics, patients with a body weight of less than 50 kg will not be included in the study.
Patients in both groups will undergo sensory examination every 5 minutes for 30 minutes after FICB is performed (sensory: 0, hypoesthesia: 1, no sensation: 2). Sensory examination scoring will be performed and recorded separately for femoral nerve, lateral femoral cutaneous nerve and obturator nerve derivations. Patients with NRS 0-4 and a total sensory scale score for three leads 3 out of 6 will be considered suitable for positioning spinal anesthesia. Among these patients, patients with a sensory scale of 5 and 6 points will be considered as complete block, and their full block duration will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergo femoral fracture surgery
- •ASA 1-2-3
- •18 years and older
- •Accepting preoperative fascia iliaca compartment block application
排除标准
- •Patients younger than 18 years
- •Patients with an ASA score of 4 and greater than 4
- •Patients who are unable to read, understand and sign the consent form
- •Patients who do not want to sign the consent form
- •Patients deemed unsuitable by the investigator
- •Patients with body weight less than 50 kg
- •Patients with hypersensitivity to local anesthetics
- •Patients with known neuropsychiatric disease
- •Patients with coagulopathic disease or anticoagulant drug use that interferes with the application of neuraxial anesthesia or peripheral nerve blockade
- •Patients with infection or active skin lesion at the application site of neuraxial anesthesia or peripheral nerve blockade
- •Patients who need to be switched to general anesthesia due to spinal anesthesia insufficiency or complications before the operation is completed
结局指标
主要结局
Morphine Consumption
时间窗: 24 hours
postoperative morphine consumption will be recorded as milligrams for first 24 hours by intravenous patient controlled analgesia (PCA) (mg/24 hours)
次要结局
- Baseline Pain(0. hours)
- Positional Pain(0. hours)
- Postoperative 2nd Hour Pain(2. hours)
- Postoperative 8th Hour Pain(8. hours)
- Postoperative 16th Hour Pain(16. hours)
- Postoperative 24th Hour Pain(24. hours)
研究者
Damla kocak
Research Assistant
Ankara City Hospital Bilkent