Comparison of the Effectiveness of Lumbar Plexus Block and Unilateral Spinal Anaesthesia 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
- 115
- 试验地点
- 1
- 主要终点
- intraoperative haemodynamic parameters
研究概览
简要总结
Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.
Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.
Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>60 years and <90 years
- •ASA (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
研究组 & 干预措施
lumbar plexus block
A 10-15 cm peripheral block needle, ultrasound and nerve stimulator will be used for lumbar plexus block. Buvicaine with 0.5% Bupivacaine Hydrochloride active substance will be used. It will be diluted half and half with saline. It will be applied in accordance with the patient's height and weight.
干预措施: lumbar plexus block (Procedure)
hypobaric spinal anaesthesia
A 25 gauge Quincke needle will be used for spinal anesthesia. After positioning the patient on the side to be operated on, an incision will be made in the appropriate space (L3-4 or L4-5) to administer hypobaric spinal anesthesia. Once a feeling of falling is obtained in the subdural region, the flow of cerebrospinal fluid will be observed, and a solution of 0.5% bupivacaine and distilled water, containing the active ingredient bupivacaine hydrochloride, will be administered.
干预措施: hypobaric spinal anaesthesia (Procedure)
hyperbaric spinal anaesthesia
25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 0.5% hyper Bupivacain hydrochloride active ingredient will be applied .
干预措施: hyperbaric spinal anesthesia (Procedure)
结局指标
主要结局
intraoperative haemodynamic parameters
时间窗: intraoperative 2 hours
non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)
次要结局
- Intraoperative bleeding(intraoperative 2 hours)
- Entropy(intraoperative 2 hours)
- SPI(intraoperative 2 hours)
- sedation and analgesic(intraoperative 2 hours)
研究者
Korgün Ökmen
Principal Investigator
Bursa Yuksek Ihtisas Training and Research Hospital