Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Sensory block
研究概览
简要总结
The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in doses achieving approximately an ED 50.
详细描述
Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date .
Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients scheduled for elective c section
- •Stillborn
- •Normal cardiotocogram
排除标准
- •BMI>35kg/m2
- •Height <150cm or >185cm
- •Age (<18, >40)
- •ASA > II
- •Multiple gestation
- •Pregnancy complications (eclampsia, GDP, placenta previa, >2 previous c section)
- •Contraindication to spinal anaesthesia
- •Failure to educate the patient, language barrier
- •Patient preferred GA
研究组 & 干预措施
Group B
subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%
干预措施: Bupivacaine plain (Drug)
Group R
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%
干预措施: Ropivacaine plain (Drug)
Group LB
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%
干预措施: Levobupivacaine plain (Drug)
Group RF
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl
干预措施: ropivacaine plain +. fentanyl (Drug)
Group BF
subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
干预措施: bupivacaine plain +fentanyl (Drug)
Group LBF
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
干预措施: Levobupivacaine plain +fentanyl (Drug)
结局指标
主要结局
Sensory block
时间窗: up to 150 minutes average
sensory block (pin prick test): every 1 min until 30min, every 5 min until 60min. every 10 min until regression to O1 (average 150 minutes)
Motor block
时间窗: up to 150 minutes
Motor block (Bromage scale): every 1 min until 30min, every 5 min until 60min. every 10 min until complete recovery of motor function (average 150 minutes)
次要结局
- Hemodynamics profile (arterial pressure. heart rate)(up to 150 minutes average)
研究者
Nikolaos G. Flaris
Anesthesiologist,MD
University of Patras