A Comparison of the Efficacy of Lumbar and Sacral Plexus Block Versus Fascia Iliaca Block Combined With Low-Dose Spinal Anesthesia in Patients Undergoing Surgery for a Femoral Neck Fracture
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Severe Intraoperative Hypotension
研究概览
简要总结
Femoral neck fracture surgery in elderly patients is frequently complicated by intraoperative hypotension and inadequate postoperative analgesia. Regional anesthesia techniques are increasingly preferred to reduce hemodynamic instability and improve pain control. This prospective observational study aims to compare the efficacy of lumbar and sacral plexus block with fascia iliaca block combined with low-dose spinal anesthesia in terms of severe intraoperative hypotension and postoperative analgesic outcomes in patients undergoing surgery for femoral neck fracture.
详细描述
The global incidence of hip fractures continues to rise, and most patients require surgical intervention. Due to advanced age, frailty, and multiple comorbidities, anesthetic management in this population is particularly challenging. Intraoperative hypotension has been shown to be associated with increased short- and long-term mortality, regardless of the anesthetic technique used.
To reduce the incidence of hypotension, various neuraxial and peripheral nerve block techniques have been investigated. While spinal anesthesia provides reliable surgical conditions, it may still cause significant hypotension. Peripheral nerve blocks, such as lumbar and sacral plexus blocks or fascia iliaca block, tend to preserve hemodynamic stability and are associated with a lower incidence of motor blockade.
Recently, combined techniques using low-dose spinal anesthesia together with fascial plane blocks have been introduced to balance the advantages of neuraxial anesthesia and peripheral nerve blocks. However, there is still no consensus on the optimal regional anesthesia strategy to minimize severe hypotension while ensuring effective analgesia in patients undergoing femoral neck fracture surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •>18 years and <90 years
- •American Society of Anesthesiologists score between I and IV
- •Patients who will undergo femoral neck fracture surgery
排除标准
- •Previous local anesthetic allergy
- •Those with bleeding diathesis disorder
- •Having a mental disorder
- •Those who are allergic to the drugs used
- •Patients who did not consent to participate in the study
- •Presence of infection in the block area
- •Body mass index >30
- •Preoperative or intraoperative general anesthesia
- •Patients for whom consent cannot be obtained
- •Pregnant patients
结局指标
主要结局
Incidence of Severe Intraoperative Hypotension
时间窗: Intraoperative period
Severe hypotension defined as mean arterial pressure (MAP) \< 65 mmHg lasting longer than 12 minutes during surgery
次要结局
- intraoperative haemodynamic parameters(intraoperative 2 hours)
- Total Intraoperative Sedative and Analgesic Drug Consumption(intraoperative 2 hours)
- Estimated Intraoperative Blood Loss (mL)(intraoperative 2 hours)
- Postoperative Pain Intensity Assessed by the Numeric Rating Scale (NRS)(postoperative 24 hour)
- Intraoperative Vasopressor Consumption(Intraoperative period)
- Length of Hospital Stay (days)(From the day of surgery through hospital discharge (up to 30 days))
研究者
Korgün Ökmen
Principal Investigator
Bursa Yuksek Ihtisas Training and Research Hospital