Comparison Between Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia for Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 主要终点
- Successful spinal puncture attempt number
研究概览
简要总结
The aim of this study was to compare the successful spinal puncture among patients with pendant position in comparison with those who used traditional sitting position for caesarean section.
详细描述
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were divided into Group A for traditional sitting position (n=154) and Group B for pendant position (n=154). The outcome parameters recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and the duration to perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value. Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square test.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women aged 18-45 years old
- •Body Mass Index (BMI) 18-35 kg/m2
- •physical status American Society of Anesthesiologists (ASA) I-III
- •planned to undergo cesarean section with spinal anesthesia and signed the informed consent form
排除标准
- •Patients with any contraindication for spinal anesthesia (infection on injection site, coagulation disorder, severe hypovolemia, increased intracranial pressure, aortic and/or mitral stenosis)
- •pregnancy with head entrapment of the fetus, umbilical cord prolapse, feet presentation,
- •Patient with eclampsia
- •Patient with cardiovascular diseases
- •Patient with scoliosis
- •Patient with history of lumbar surgery
- •Patient with unpalpable intervertebral space due to thick fatty tissue or edema.
- •Drop out criteria:
- •spinal block was failed or only partial block
研究组 & 干预措施
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 before spinal anesthesia begun.
干预措施: Traditional sitting position (Procedure)
Pendant position
Patients sit with both their underarms propped up on a metal prop, thus both arms hanging from the prop before spinal anesthesia begun.
干预措施: Pendant position (Procedure)
结局指标
主要结局
Successful spinal puncture attempt number
时间窗: 2 months
The number of attempt for the successful spinal puncture for each positions
The number of spinal needle-bone contact
时间窗: 2 months
The number of spinal needle-bone contact for each positions
Spinal puncture duration
时间窗: 2 months
the duration to perform spinal puncture for each positions
次要结局
未报告次要终点
研究者
Pryambodho Pryambodho
Consultant, Anesthesiologist
Indonesia University