Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Postoperative pain levels during movement (cough)
研究概览
简要总结
To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.
详细描述
Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain.
It is unclear which anesthetic technique provides better pain relief after cesarean section.
This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.
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
- None
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
- •Female patients aged greater than or equal to 18 years
- •Patients without severe illnesses (American Society of Anaesthesiologists [ASA] grade II-III)
- •Patients for elective cesarean sections
- •Informing patients about risks and complications of anesthesia until 24 hrs before operation
排除标准
- •Lacking willingness to regional procedures
- •No offered patient information and written informed consent
- •Persons without the capacity to consent
- •Unability of German language use
- •Preterm delivery < 28 weeks of pregnancy
- •Chronic pain or chronic analgesic intake in medical history
- •Alcohol, dope and medication abuse
- •Psychiatric disease in medical history
- •Baby death after delivery
- •Anxiolytic medication
- •Allergy to local anaesthetics
- •History of bleeding tendency
- •Eclampsia and HELLP syndrome
- •Elective section out work routine time
- •Participation in another clinical trial during the trial, one month before screening and three months after screening
结局指标
主要结局
Postoperative pain levels during movement (cough)
时间窗: At nine hours after the end of surgery (closure time)
Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS)
次要结局
- Postoperative pain levels during rest(At nine hours after the end of surgery (closure time))
- Postoperative pain levels during rest and movement(At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time))
- Change of type of anesthesia when regional anesthesia fails(During the operation)
- Level of anesthesia during the operation(During the operation)
- Incidence of hypotensions during the operation(During the operation)
- Sedation level (Ramsay-Score)(Postoperative course)
- Capability for mobilisation and time to first mobilisation(Postoperative course)
- Incidence of adverse reactions (PONV, headache and backpain, urinary retention)(Postoperative course)
- Satisfaction with pain management(Postoperative course)
- Co-analgesics(In the 48-hour postoperative sample period)
研究者
Christian von Heymann, M.D.
Prof. Dr. med. Christian von Heymann, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charite University, Berlin, Germany.
Charite University, Berlin, Germany