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临床试验/NCT03407209
NCT03407209已完成不适用

Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 462 人开始时间: 2016年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
462
试验地点
1
主要终点
consumption of local anesthetic

研究概览

简要总结

Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated.

However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage.

Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction.

While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.

详细描述

Local anesthetic used: levobupivacaine 0,625mg/ml

Solution prepared with 200 ml of levobupivacaine 0,625mg/ml associated with analgesic adjuvants: sufentanyl 50 micrograms and clonidine 75 micrograms.

Randomization between:

  • PEIB:
  • automatic hourly bolus: 8ml (5mg) on 3 min
  • patient controlled bolus: 8ml (5mg) on 3 min
  • refractory period: 8min
  • continuous infusion: 0
  • maximum dose: 65mg/4h

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
Single (Participant)

入排标准

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

入选标准

  • Informed consent
  • Age >/= 18 years
  • Nulliparous
  • >35 weeks of amenorrhea
  • In spontaneous or triggered labor

排除标准

  • Contraindication for epidural analgesia (pre-partum hemostasis troubles, infection)
  • Multiple pregnancy
  • Fetal death in utero
  • Programmed or in emergency caesarian

研究组 & 干预措施

PEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml

Sham Comparator
  • automatic hourly bolus: 8ml (5mg) on 3 min
  • patient controlled bolus: 8ml (5mg) on 3 min
  • refractory period: 8min
  • continuous infusion: 0
  • maximum dose: 65mg/4h

干预措施: consumption of local anesthetic measurement (Other)

FREE programming - levobupivacaine anesthetics: 0.625 mg / ml

Experimental

Epidural analgesia totally controlled by the patient

  • automatic hourly bolus: 0
  • patient controlled bolus: 8ml (5mg) on 3 min
  • refractory period: 8min
  • continuous infusion: 0
  • maximum dose: 65mg/4h

干预措施: consumption of local anesthetic measurement (Other)

结局指标

主要结局

consumption of local anesthetic

时间窗: during delivery

次要结局

  • Incidence of oxytocin administration(during delivery)
  • Incidence of motor block(during delivery)
  • Incidence of dystocia(during delivery)
  • Incidence of instrumental delivery(during delivery)
  • Incidence of caesarian(during delivery)
  • the evaluation of pain by a numerical scale rated from 0 to 10(during delivery)
  • Patient satisfaction with Likert type scale from A: excellent to E: catastrophic for the overall experience(during delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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