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临床试验/NCT03395600
NCT03395600已完成4 期

A Randomized Controlled Comparison of Different Dose Combinations of Bupivacaine and Sufentanil on Epidural Analgesia Onset Time and Adverse Reactions During Labor

Fudan University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
56
试验地点
1
主要终点
the time to achieve effective analgesia

研究概览

简要总结

This study aimed to compare the effects of three commonly used combination doses on the onset time and adverse reactions.

详细描述

Epidural block is widely used as an analgesic method during labor. During epidural anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics to prolong the duration of analgesia and improve the analgesic effect. However, dose combinations of local anesthetics and opioids, especially in the initial loading dose, vary greatly from hospital to hospital and often depend upon the different routines adopted by anesthesiologists. In clinical practice, there are still some controversy about opioid dose selection in terms of analgesic onset time and adverse reactions.

In this study, three combinations of bupivacaine and sufentanil were chosen, commonly used in the clinic, and extended the observation period to 24 hours after delivery. We hypothesized that increasing the concentration of local anesthetic, rather than increasing the dose of sufentanil, would achieve a faster analgesic effect with minimal adverse effects on the mother and fetus. To test our hypothesis, our primary outcome was to compare the times of analgesia onset of the three combinations, and the secondary outcomes were to compare the effects on maternal and infant adverse reactions.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients ASA physical status 1 or 2; early labour (cervical dilation 5 cm or less); singleton fetus; gestational age > 36 weeks; and normal fetal heart rate (FHR) tracing. -

排除标准

  • severe preeclampsia;antepartum haemorrhage; ASA 3 or more; chronic pain; substance abuse;contraindications to epidural analgesia; allergies to local anaesthetics or fentanyl; body mass index (BMI) over 40; and previous administration of opioid analgesia within 24 h.

研究组 & 干预措施

0.1%bupivacaine+10µg sufentanyl

Active Comparator

Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected

干预措施: B1S10 (Drug)

0.125%bupivacaine+5µg sufentanyl

Active Comparator

Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose. After 3 min, 10 ml of 0.125% bupivacaine epidural was injected

干预措施: B125S5 (Drug)

0.1%bupivacaine+5µg sufentanyl

Active Comparator

Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected

干预措施: B1S5 (Drug)

结局指标

主要结局

the time to achieve effective analgesia

时间窗: 30 min

We defined the onset of analgesia as the time from the start of the injection to the time when the NPRS score was reduced to at least half of the original score.

次要结局

  • time from the first PCA bolus, patient satisfaction, type of delivery, fever, establishment of breast feeding and LATCH score within 24 h, cumulative dosage of sufentanil/bupivacaine, time from bolus to delivery.(delivery 24h)
  • Sensory block, maternal side effects (pruritus, hypotension, sedation,motor block and decreased fetal heart rate) were recorded at 5-min intervals for 30 min. sedation)(30min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tingting Wang

Fudan University

研究点 (1)

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