Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cathecolamines levels
研究概览
简要总结
Combined spinal-epidural (CSE) for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, possibly due to asymmetric decrease in catecholamine levels, when compared with epidural analgesia (EP).
详细描述
Background: Combined spinal-epidural technique for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, when compared with epidural analgesia, possibly due to asymmetric decrease in catecholamine levels (epinephrine and norepinephrine) following neuraxial block. However, there are no studies comparing plasmatic catecholamine levels between those two techniques. This study aimed to compare spinal-epidural versus epidural regarding pre and post-analgesia catecholamine levels, uterine tone and fetal heart rate.
Methods: Randomized clinical trial with 47 laboring patients divided in two groups. Primary outcome was plasmatic catecholamine measurements before and after neuraxial block. Secondary outcomes were fetal heart rate changes, uterine hypertonia, hypotension episodes, pain relief and fetal outcomes.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients aged over 18 years were included when they requested labor analgesia. The inclusion criteria were: patients between 37 and 42 gestational weeks, single pregnancy, in active labor (induced or spontaneous), requesting analgesia with 7 cm or less of cervical dilation. As it is a center that attends only high-risk pregnancies, ASA II or III
排除标准
- •Contraindications to interventions, either due to severe comorbidity or contraindication to neuraxial block; previous use of systemic opioids during labor, maternal amniotic infection or known fetal diseases
研究组 & 干预措施
Puncture epidural
Women in labor the epidural group will receive epidural bupivacaine with vasoconstrictor 0.125% 10 ml plus 20 micrograms sufentanil, followed by the placement of the epidural catheter
干预措施: Epidural bupivacaine with vasoconstrictor 0.125% (Drug)
Puncture epidural
Women in labor the epidural group will receive epidural bupivacaine with vasoconstrictor 0.125% 10 ml plus 20 micrograms sufentanil, followed by the placement of the epidural catheter
干预措施: Epidural sufentanil (Drug)
Puncture epidural
Women in labor the epidural group will receive epidural bupivacaine with vasoconstrictor 0.125% 10 ml plus 20 micrograms sufentanil, followed by the placement of the epidural catheter
干预措施: Placement of the epidural catheter (Procedure)
Puncture combined spinal-epidural
The mothers of the combined spinal-epidural analgesia group will receive intrathecal hyperbaric bupivacaine solution 0.5% 2.5 mg plus 5.0 micrograms of sufentanil and plus 60 micrograms of morphine, followed by placement of an epidural catheter to the catheter through technical needle
干预措施: Intrathecal hyperbaric bupivacaine solution 0.5% (Drug)
Puncture combined spinal-epidural
The mothers of the combined spinal-epidural analgesia group will receive intrathecal hyperbaric bupivacaine solution 0.5% 2.5 mg plus 5.0 micrograms of sufentanil and plus 60 micrograms of morphine, followed by placement of an epidural catheter to the catheter through technical needle
干预措施: Intrathecal morphine (Drug)
Puncture combined spinal-epidural
The mothers of the combined spinal-epidural analgesia group will receive intrathecal hyperbaric bupivacaine solution 0.5% 2.5 mg plus 5.0 micrograms of sufentanil and plus 60 micrograms of morphine, followed by placement of an epidural catheter to the catheter through technical needle
干预措施: Placement of an epidural catheter to the catheter through technical needle (Procedure)
Puncture combined spinal-epidural
The mothers of the combined spinal-epidural analgesia group will receive intrathecal hyperbaric bupivacaine solution 0.5% 2.5 mg plus 5.0 micrograms of sufentanil and plus 60 micrograms of morphine, followed by placement of an epidural catheter to the catheter through technical needle
干预措施: Intrathecal sufentanil (Drug)
结局指标
主要结局
Cathecolamines levels
时间窗: at the moment of analgesia and 20 minutes after
Pattern of cathecolamines levels
Fetal bradycardia
时间窗: 15 minutes before analgesia and 30 minutes after continuously
Fetal bradycardia is defined as the baseline drops to less than 100 bpm
Increase in uterine tone
时间窗: 15 minutes before analgesia and 30 minutes after continuously
Increase in uterine tone (qualitative measure)
次要结局
- Maternal hipotension(30 minutes after analgesia (measures every 5 minutes))
研究者
SHIRLEY ANDRADE SANTOS
Anesthesiologist
University of Sao Paulo General Hospital