单侧脊髓麻醉与神经阻滞在髋部骨折中的比较
腰椎丛阻滞与低比重单侧蛛网膜下腔阻滞在股骨颈骨折手术患者中的有效性比较
This randomized study aims to compare the efficacy and hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. Conducted at a single center, the study includes 60 patients aged 18 to 90, classified as ASA I-IV, and evaluates anesthesia methods' impact on intraoperative parameters, including blood pressure, sedation needs, and recovery outcomes. The findings will inform anesthetic strategy selection based on patient characteristics and surgical requirements.
研究概览
地位
详细说明
This prospective, randomized, controlled study is designed to compare hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block combined with sacral plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. The study will be conducted at Bursa Yüksek İhtisas Training and Research Hospital and will include a total of 60 patients aged between 18 and 90 years with ASA physical status I-IV.
Eligible patients will be randomized into two groups: the HUSA group and the LP-SP group. In the HUSA group, unilateral spinal anesthesia will be performed using 5 mg of 0.5% bupivacaine diluted with distilled water to achieve a hypobaric solution. In the LP-SP group, lumbar plexus block and sacral plexus block will be performed using ultrasound-guided Shamrock or paramedian sagittal approaches with 0.5% bupivacaine.
Standard intraoperative monitoring will be applied to all patients, including electrocardiography, non-invasive blood pressure, pulse oximetry, and anesthesia depth monitoring with entropy and surgical pleth index. Intraoperative sedation, vasopressor use, and intravenous fluid administration will be managed according to institutional clinical protocols and patient needs.
Hemodynamic parameters, anesthesia depth indices, nociception indices, sedation requirements, and recovery-related parameters will be recorded intraoperatively at predefined time points. All data will be collected prospectively and analyzed to compare the two anesthetic techniques in terms of intraoperative stability and perioperative management requirements.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bursa、土耳其（türkiye）
- Healt Science University Bursa Yuksek Ihtisas Research and Education Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 90 years.
- American Society of Anesthesiologists (ASA) classification I-IV.
- Scheduled for femoral neck fracture surgery.
- Provided informed consent to participate in the study.
Exclusion Criteria:
- History of allergy to local anesthetics.
- Presence of coagulopathy or bleeding disorders.
- Mental health disorders impairing consent or cooperation.
- Allergy to medications used in the study protocol.
- Presence of infection at the block site.
- Body mass index (BMI) > 30.
- Preoperative or intraoperative conversion to general anesthesia.
- Pregnant patients.
- Severe spinal deformities preventing regional anesthesia application.
- Refusal to participate in the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：低比重单侧脊髓麻醉组
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Patients in this group receive hypobaric unilateral spinal anesthesia (HUSA) using 5 mg of 0.5% bupivacaine diluted with 3 mL of distilled water. The injection is administered at the L4-L5 intervertebral space in the lateral position. Hemodynamic parameters, sensory block levels, and intraoperative requirements are monitored. |
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实验性的：腰丛神经阻滞组
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Patients in this group undergo lumbar plexus block (LP-SP) using a Shamrock or paramedian sagittal ultrasound-guided approach. A mixture of 0.5% bupivacaine and saline (total volume: 25-35 mL) is administered based on patient body weight (max 2.5 mg/kg). Neurostimulation is used to confirm accurate needle placement in the psoas muscle. Hemodynamic stability, block efficacy, and sedation needs are assessed. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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State Entropy(SE)
大体时间：Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
|
To measure the depth of anesthesia using the State Entropy (SE) index during surgery. SE reflects cortical EEG activity and ranges from 0 to 91. Lower SE values indicate deeper levels of anesthesia. Measurements will be recorded intraoperatively at baseline and at 5, 15, 30, 45, 60, 90, and 120 minutes, as well as at the end of surgery. |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
|
|
Response Entropy(RE)
大体时间：Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
|
To measure the depth of anesthesia using the Response Entropy (RE) index during surgery. RE reflects combined cortical EEG and facial muscle activity and ranges from 0 to 100. Lower RE values indicate deeper levels of anesthesia. Measurements will be recorded intraoperatively at baseline and at 5, 15, 30, 45, 60, 90, and 120 minutes, as well as at the end of surgery. |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Surgical Pleth Index (SPI)
大体时间：Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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To assess intraoperative nociception and stress levels using the Surgical Pleth Index (SPI). The SPI reflects autonomic responses to surgical stimuli and ranges from 0 to 100. Higher SPI values indicate higher nociception and stress. Measurements will be |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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Intraoperative Blood Pressure Changes
大体时间：Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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To monitor systolic, diastolic, and mean arterial blood pressure changes during surgery. |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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Sedative Drug Requirement
大体时间：Entire surgery duration
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Total amount of sedative medications administered intraoperatively, including propofol and fentanyl. The cumulative dose will be recorded throughout the entire surgery duration (propofol in milligrams; fentanyl in micrograms). |
Entire surgery duration
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Total Intravenous Fluid Volume
大体时间：Entire surgery duration
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Total volume of intravenous fluids administered intraoperatively. The cumulative fluid amount will be recorded in milliliters (mL) during the entire surgery duration. |
Entire surgery duration
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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