Assessment of Sensory and Motor Block After Intrathecal Administration of Bupivacaine, Ropivacaine and Levo-bupivacaine Combined With Small Doses of Fentanyl, Followed by Administration of Normal Saline Epidurally:a Clinical Trial in Parturients Scheduled for C-section
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Dermatomes of Sensory block
研究概览
简要总结
Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.
详细描述
Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.
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
- Triple (Participant, 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
- •Elective cesarean section
排除标准
- •complicated pregnancy (i.e preeclampsia, eclampsia,arterial hypertension, diabetes mellitus)
- •abnormal fetal heart rate at the time of admission
- •body mass index > 35 kg/m2
- •height <150cm and >185 cm
- •age <18 yrs and >40 yrs
- •patients with contraindication to spinal anaesthesia( i.e anticoagulants)
- •ASA >III
- •intraoperative excessive bleeding
- •patients with previous psychiatric diseases
研究组 & 干预措施
Group BFS
Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
干预措施: Bupivacaine- Fentanyl - Normal Saline (Drug)
Group RFS
Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
干预措施: Ropivacaine-Fentanyl-Normal Saline (Drug)
Group LFS
Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
干预措施: Levobupivacaine- Fentanyl- Normal Saline (Drug)
BupivacaineF
Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY
干预措施: Bupivacaine + Fentanyl (Drug)
RopivacaineF
Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.
干预措施: Ropivacaine + Fentanyl (Drug)
LevobupivacaineF
Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
干预措施: Levobupivacaine + Fentanyl (Drug)
结局指标
主要结局
Dermatomes of Sensory block
时间窗: up to 120 minutes average
Dermatomes of sensory block(pin prick test) are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal of sensory block
Motor block
时间窗: up to 120 minutes average
Motor block according to the Bromage scale are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal motor block
次要结局
- Arterial Blood Pressure(up to 120 minutes average)
研究者
SKLAVOU CHRISTINA
Anesthesiologist- MD
University of Patras