Comparison of Successful Spinal Needle Placement Between Crossed Leg Sitting Position and Traditional Sitting Position in Patients Underwent Urology Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- One shot successful spinal needle placement
研究概览
简要总结
The study aimed to compare successful spinal needle placement between crossed leg sitting position and traditional sitting position in patients underwent urology surgery.
详细描述
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were randomly divided into CLSP Group for crossed leg sitting position (n=105) and TSP Group for traditional sitting position (n=106). Non-invasive blood pressure (NIBP) monitor, eletrocardiography (ECG), oxygen nasal cannula and pulse-oxymetry was set on the subjects in the operation room. Baseline information was recorded. Spinal anesthesia was done by anesthesiology registrars that have done 50 spinal anesthesia procedures and have been explained about the protocol of spinal anesthesia injection in this study (to avoid bias). Outcome measures were the number of successful spinal needle placement in the first attempt, the difficulty level of landmark palpation for injection, and the number of needle-bone contact. Data was analyzed by SPSS (Statistical Package for Social Scientist) using Chi-Square test, Fisher Exact test, and Kolmogorov-Smirnov test. Significance value used was 5% with 80% power.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged 18-60 years old-
- •subjects with ASA physical status I-III who were planned to undergo urology surgery with spinal anesthesia
- •Subjects who have been explained about the study, have agreed to enroll and have signed the informed consent form
排除标准
- •uncooperative subjects
- •subjects with relative and absolute contraindications to spinal anesthesia (coagulation disorders, thrombocytopenia, increases intracranial pressure, severe hypovolemia, severe heart valve disorders, local infection at the injection site, allergy toward local anesthetic agents, significant anatomical disorder of the spine, wound/scar on the lumbal area)
- •subjects with body mass index (BMI) > 32 kg/m2
- •Drop out criteria:
- •subjects who requestes to drop out of the study
- •subjects in need of emergency treatment during spinal anesthesia procedure
- •subjects with more than nine times redirected spinal needle (failed spinal anesthesia procedure).
研究组 & 干预措施
TSP Group
Those with traditional sitting position: patient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion.
干预措施: Traditional sitting position (Procedure)
CLSP Group
Those with cross leg sitting position: patients sit with both their knees flexed medially, hip flexed, resulting in pelvic leaning posteriorly and reducing lumbal lordosis.
干预措施: Cross leg sitting position (Procedure)
结局指标
主要结局
One shot successful spinal needle placement
时间窗: 7 months
The number of successful spinal needle placement in the first attempt
Needle-bone contact number
时间窗: 7 months
The number of needle-bone contact recorded.
The difficulty level of landmark palpation for injection
时间窗: 7 months
the difficulty level of landmark palpation for injection were assessed as easy or difficult.
次要结局
- Spinal needle placement complications(7 months)
研究者
Sidharta K. Manggala
Consultant, Anesthesiologist
Indonesia University