Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine at Different Rates; Does it Make Difference?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate (normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed block were recorded.
详细描述
56 ASA physical status I, II Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate through a 5ml syringe each (NS (normal sequential), n 28) or a rapid intrathecal injection of fentanyl through an insuline syringe followed by slow injection of hyperbaric bupivacaine through a 5ml syringe RS (rapid sequential), n 28). Onset of sensory block (T6 level), highest level of sensory block, time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain by VAS 6H postoperative, Onset of motor block (Bromage scale0>3), duration of motor block (return to Bromage 0), incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications as nausea, vomiting, pruritis, shivering and failed block were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •ASA I, II
- •Parturients aged from 18-40 years old
- •scheduled for elective CS
排除标准
- •parturients with complicated pregnancy as (preeclampsia, pregnancy induced HTN, gestational Diabetes, abnormal placenta (placenta previa), multiple gestation),
- •BMI greater than 35 or less than 22,
- •major systemic disease (cardiac, renal, liver),
- •need for emergency CS,
- •having allergy to drugs used in the study,
- •having contraindication for spinal anaesthesia or
- •refused regional anaesthesia
研究组 & 干预措施
sequential intrathecal injection of fentanyl and bupivacaine
intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially
干预措施: sequential intrathecal injection (Procedure)
sequential intrathecal injection of fentanyl and bupivacaine
intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially
干预措施: hyperbaric bupivacaine (Drug)
sequential intrathecal injection of fentanyl and bupivacaine
intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially
干预措施: fentanyl (Drug)
rapid sequential intrathecal injection of fentanyl and bupiva
intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.
干预措施: sequential intrathecal injection (Procedure)
rapid sequential intrathecal injection of fentanyl and bupiva
intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.
干预措施: hyperbaric bupivacaine (Drug)
rapid sequential intrathecal injection of fentanyl and bupiva
intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.
干预措施: fentanyl (Drug)
结局指标
主要结局
Duration of postoperative analgesia
时间窗: 2-5 hours
technique provides prolonged post operative analgesia
次要结局
- incidence of hypotension(30 minutes)
研究者
Rania Maher Hussien
principle investigator
Ain Shams University