Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Change the sensory block level at intraoperative period by pinprick test
研究概览
简要总结
The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.
详细描述
Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal anesthesia was performed with one of the following regimens.
Group 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction motor block was evaluated via bromage scale and sensory block via pinprick test every 3 minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block level, time to reach maximum block level, time needed to achieve T10 sensory level were recorded.
Baby delivery time, and operation duration were also recorded. Time to two segment regression of maximum sensory block, motor block recovery time and time to S2 regression of sensory block will be recorded.
Hemodynamic data, nausea vomiting, were also recorded throughout surgery at the same evaluation periods and postoperative period.
The surgeon will also evaluate the abdominal relaxation surgical block quality as good, medium and poor.
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
- Triple (Participant, 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
- 是
入选标准
- •Pregnancy at Term
- •Scheduled for elective caesarean delivery
排除标准
- •contraindication for spinal anesthesia
- •drug allergy
- •pregnancy related disorders (hypertension, placenta previa, fetal problems)
研究组 & 干预措施
Plain Levobupivacaine (Chirocaine (% 0.5)
Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain
干预措施: Chirocaine %0.5 (Drug)
Levobupivacaine (Chirocaine % 0,75) + dextrose 40
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40
干预措施: Chirocaine Heavy 40 (Drug)
Levobupivacaine (Chirocaine % 0,75) + dextrose 60
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60
干预措施: Chirocaine Heavy 60 (Drug)
Levobupivacaine (Chirocaine % 0,75) + dextrose 80
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80
干预措施: Chirocaine Heavy 80 (Drug)
结局指标
主要结局
Change the sensory block level at intraoperative period by pinprick test
时间窗: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The highest measured level by pinprick test be recorded
the level of maximum sensory block by pinprick test
Change in motor block level from PACU to discharge
时间窗: every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale
motor block recovery time by bromage scale
Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test
时间窗: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia.In these evaluation periods, the sensory block will be recorded when the T10 is detected.
time to reach T10 sensory block by pinprick test
Spinal Block Quality by questioning
时间窗: At the end of surgery
the intensity of spinal block will be evaluated via questioning the surgeon and the patient. the surgeon will grade the abdominal relaxivity as good, medium or poor The patient will evaluate spinal block analgesia quality as good, medium or poor.
Change over time at the level of sensory block at intraoperative period by pinprick test
时间窗: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The time to two segment regression of maximum sensory block by pinprick test will be recorded.
time to two segment regression of maximum sensory block by pinprick test
time to reach maximum level of sensory block at intraoperative period by pinprick test
时间窗: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. the time to reach the highest measured by pinprick test will be recorded.
time to reach maximum level of sensory block by pinprick test
Change to regression of sensory block by pinprick test
时间窗: In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours
time to S2 regression of sensory block by pinprick test
次要结局
- Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure(Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. every 30 minutes up to 2 hours)
- Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone(on postoperative day 3 by phone.)
- evaluation of umbilical vein blood gas analysis(immediately after fetus delivery)
研究者
Ozlem Sagir, MD
Associated Professor
Balikesir University