Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section - a Retrospective Analysis of High Hyperbaric Bupivacaine Dose Cases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Assessed variable - block level correlation coefficient
研究概览
简要总结
This study is designed to assess possible relation between the anthropometric data of pregnant women at term, as well as their babies, and the maximal level of sensory blockade following spinal anesthesia for cesarean section. The debate regarding this relation is ongoing. Although there is some relevant data in favor of both lack and the presence of significant relation between these variables, it is still not clear whether the same dose of local anesthetic is similarly effective, regardless of parturient's and fetal size.
详细描述
Spinal block is a gold standard of cesarean section anesthesia. Two major factors contribute to its popularity: more than satisfactory level of surgical conditions and the fact that the mother is able to witness the birth of her child and both of them can benefit from skin-to-skin contact. For the procedure to proceed with patient's comfort the level of sensory block is required to be adequately high, reaching high thoracic dermatomes.
For this reason the quest for the ideal dose of local anesthetic is still ongoing. A few strategies has been proposed. Adjusting the dose to patient's size is probably the most popular. In order to minimize the risk of spinal block - related complications and maintain acceptable level of effectiveness, it was suggested that height, weight, maternal weight gain, abdominal circumference or combination of these variables may be used to calculate the appropriate spinal dose of hyperbaric bupivacaine.
In this study we will investigate whether demographic variables relate to maximal level of spinal sensory blockade when the same high dose of local anesthetic is used (close to the dose effective in 95% of cases (ED95)).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cesarean delivery at term under spinal anesthesia
- •American Society of Anesthesiologists (ASA) physical status <3
排除标准
- •Spinal anesthesia with the dose different than 12.5mg of hyperbaric bupivacaine
- •Local anesthetic other than hyperbaric bupivacaine used
- •Failed spinal anesthesia
- •Poor quality of anesthetic record - required data not available
研究组 & 干预措施
Parturients given spinal block with 12.5mg of hyperbaric bupivacaine
Hospital's electronic database will be searched in order to identify elective cases of cesarean sections performed under spinal anesthesia. After that, a manual review of each case will follow and only those where the dose of hyperbaric bupivacaine used for spinal block was 12.5mg will be chosen for further analysis. Anesthetic records of these cases will be retrieved and assessed for its quality, clarity and completeness. During the process of further analysis an anonymized data will be retrieved and moved to Excel file: demographic and pregnancy - related data of the parturient, spinal block - related data (technique and dynamic of the sensory blockade, maternal hemodynamic parameters) and neonatal data (birthweight). Special attention will be paid to assure that all data is accessible only for investigators and remain anonymous throughout the analysis process.
干预措施: Spinal block level analysis (Other)
Parturients given spinal block with 12.5mg of hyperbaric bupivacaine
Hospital's electronic database will be searched in order to identify elective cases of cesarean sections performed under spinal anesthesia. After that, a manual review of each case will follow and only those where the dose of hyperbaric bupivacaine used for spinal block was 12.5mg will be chosen for further analysis. Anesthetic records of these cases will be retrieved and assessed for its quality, clarity and completeness. During the process of further analysis an anonymized data will be retrieved and moved to Excel file: demographic and pregnancy - related data of the parturient, spinal block - related data (technique and dynamic of the sensory blockade, maternal hemodynamic parameters) and neonatal data (birthweight). Special attention will be paid to assure that all data is accessible only for investigators and remain anonymous throughout the analysis process.
干预措施: Data collection (Other)
Parturients given spinal block with 12.5mg of hyperbaric bupivacaine
Hospital's electronic database will be searched in order to identify elective cases of cesarean sections performed under spinal anesthesia. After that, a manual review of each case will follow and only those where the dose of hyperbaric bupivacaine used for spinal block was 12.5mg will be chosen for further analysis. Anesthetic records of these cases will be retrieved and assessed for its quality, clarity and completeness. During the process of further analysis an anonymized data will be retrieved and moved to Excel file: demographic and pregnancy - related data of the parturient, spinal block - related data (technique and dynamic of the sensory blockade, maternal hemodynamic parameters) and neonatal data (birthweight). Special attention will be paid to assure that all data is accessible only for investigators and remain anonymous throughout the analysis process.
干预措施: Sub-group analysis (Other)
结局指标
主要结局
Assessed variable - block level correlation coefficient
时间窗: Highest level of sensory block noted from the time of spinal injection until the end of surgical procedure
Regression and correlation analysis will be employed to assess the relation between pregnancy-related, maternal and neonatal data and the level of sensory block. For the purpose of statistical analysis the level of block will be converted into numbers for more reliable outcome.
次要结局
未报告次要终点
研究者
Bartosz Horosz, MD
Principal Investigator
Centre of Postgraduate Medical Education