Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in postoperative pain scores
研究概览
简要总结
The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.
详细描述
90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.
The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology risks classification II
- •Term pregnant
排除标准
- •Multiple pregnancy
- •Diabetes mellitus
- •Hypertension
- •Coagulopathy
- •Severe cardiac, neurological and pulmonary disease
- •Allergy to the study drugs
- •Difficulty in understanding the use of the patient controlled analgesia device
研究组 & 干预措施
Group 5
5 mL epidural initiation volume (bupivacaine + fentanyl)
干预措施: 5 mL epidural initiation volume (bupivacaine + fentanyl) (Drug)
Group 10
10 mL epidural initiation volume (bupivacaine + fentanyl)
干预措施: 10 mL epidural initiation volume (bupivacaine + fentanyl) (Drug)
Group 20
20 mL epidural initiation volume (bupivacaine + fentanyl)
干预措施: 20 mL epidural initiation volume (bupivacaine + fentanyl) (Drug)
结局指标
主要结局
Change in postoperative pain scores
时间窗: up to 12 hours after cesarean delivery
Visual analog scale
次要结局
- First analgesic demand time(up to 12 hours after cesarean delivery)
- The number of analgesic requirement(up to 12 hours after cesarean delivery)
- Morphine requirement(up to 12 hours after cesarean delivery)
研究者
Osman Kacmaz
Anesthesiologist
Inonu University