Comparison of the Effectiveness of Lumbar Plexus Block and Hypobaric Unilateral Spinal Anesthesia in Patients Undergoing Femoral Neck Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- State Entropy(SE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •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.
排除标准
- •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) >
- •Preoperative or intraoperative conversion to general anesthesia.
- •Pregnant patients.
- •Severe spinal deformities preventing regional anesthesia application.
- •Refusal to participate in the study.
结局指标
主要结局
State Entropy(SE)
时间窗: 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.
Response Entropy(RE)
时间窗: 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.
次要结局
- Surgical Pleth Index (SPI)(Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours])
- Intraoperative Blood Pressure Changes(Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours])
- Sedative Drug Requirement(Entire surgery duration)
- Total Intravenous Fluid Volume(Entire surgery duration)
研究者
Gokberk Kursat Ulker
Anesthesiology and Reanimation Resident
Bursa Yuksek Ihtisas Training and Research Hospital