NCT02510287已完成不适用
A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
Fundación Santa Fe de Bogota1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Pain level in laboring women measured by the Numeric Analog Scale
研究概览
简要总结
The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.
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 (Participant, 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
- •At term pregnancy
- •Laboring patients requiring epidural analgesia
排除标准
- •American Society of Anesthesiologists physical status > or equal than 3
- •allergy to local anesthesics
- •Neuraxial contraindications
- •Hemodynamic instability
- •Systemic disease such as diabetes mellitus or hypertension
- •Chronic usage of analgesics
- •Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others
研究组 & 干预措施
Continuous Epidural Infusion
Active Comparator
- An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
- A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.
- Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
- If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
干预措施: Bupivacaine and Fentanyl Initial Dose (Drug)
Continuous Epidural Infusion
Active Comparator
- An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
- A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.
- Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
- If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
干预措施: Rescue Bolus (Drug)
Continuous Epidural Infusion
Active Comparator
- An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
- A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.
- Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
- If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
干预措施: Lidocaine (Drug)
Programmed Intermittent Epidural Bolus
Experimental
- An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
- A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.
- Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
- If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
干预措施: Bupivacaine and Fentanyl Initial Dose (Drug)
Programmed Intermittent Epidural Bolus
Experimental
- An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
- A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.
- Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
- If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
干预措施: Rescue Bolus (Drug)
Programmed Intermittent Epidural Bolus
Experimental
- An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
- A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.
- Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
- If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain level in laboring women measured by the Numeric Analog Scale
时间窗: one year
to compare pain level in each arm once epidural analgesia is applied until birth
次要结局
未报告次要终点
研究者
Leopoldo Ferrer
MD anesthesiologist
Fundación Santa Fe de Bogota
研究点 (1)
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