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临床试验/NCT02963337
NCT02963337已完成不适用

Pain Relief and Progress of Labour With Remifentanil Patient-controlled Analgesia Versus Combined Spinal-epidural Analgesia in Multiparous Women: a Prospective Observational Study

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2017年1月1日最近更新:
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
入组人数
162
试验地点
1
主要终点
Pain relief with remifentanil or CSE in multiparous women

研究概览

简要总结

Remifentanil may be an ideal drug for labor analgesia due to its pharmacodynamic and pharmacokinetic profile. As compared to epidural analgesia, it demonstrated satisfactory for pain relief at the beginning of labour with a gradual elevation of pain scores as labour progresses. However, fast onset and limited time efficacy may render it useful in multiparous with a faster labor progression, thus even making it an alternative to single-shot spinal analgesia.

详细描述

Introduction:

Neuraxial analgesia is considered the most effective method of pain relief during labor. When unavailable, contraindicated, refused by parturient or discouraged by midwife/obstetrician, alternative methods of analgesia are required which should to be effective, without major side effects and flexible enough to adapt to variable analgesic requirements during labor.

Remifentanil may be an ideal drug for labor analgesia due to its pharmacodynamic and pharmacokinetic profile. It is an ultra-short-acting µ1-opioid receptor agonist, rapidly metabolized by plasma and tissue esterases. It has onset time of 30 to 60 seconds and a peak effect at 2,5 min. It rapidly crosses the placenta and it is quickly metabolized by the fetus. Several studies which compared remifentanil patient controlled analgesia (PCA) with epidural analgesia in nulliparous patients or parturient of mixed parity have demonstrated a lower analgesic efficacy of remifentanil. Remifentanil, as compared to epidural analgesia, showed a satisfactory for pain relief only at the beginning of labor with a gradual elevation of pain scores as labor progressed. However, the fast onset and limited time efficacy may render it useful in multiparous with a faster labor progression, thus even making it an alternative to single-shot spinal analgesia.

The anaesthetic technique may also affect the progress of labor. A combined spinal-epidural analgesia (CSEA) has been demonstrated to be associated with a greater cervical dilation relative to conventional epidural analgesia in nulliparous patients. There are no data on labour progression difference as compared to remifentanil PCA in multiparous.

We therefore conduct the study in multiparous patients to compare remifentanil PCA and CSEA with respect to pain relief and the progress of labor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients' request for pain relief
  • ASA physical status 1-3
  • uncomplicated singleton pregnancy with cefalic presentation
  • gestation age > 37 weeks
  • regular uterine contractions
  • cervical dilation 2-5 cm
  • anticipated vaginal delivery
  • fetus without suspected abnormality and normal CTG

排除标准

  • contraindications for remifentanil usage
  • contraindications for CSE

研究组 & 干预措施

remifentanil PCA

The patients in the remifentanil group will receive remifentanil hydrochloride (Ultiva, GlaxoSmithKline, Oslo, Norway) diluted in physiologic saline to a concentration of 40µg/ml and administered using PCA pump with a bolus duration of 20 sec. A stepwise bolus doses from 15 to 30 µg, maximum 40 per 2 min will be applied with no background infusion.

干预措施: remifentanil (Drug)

Combined spinal-epidural analgesia PCA

A 27-gauge needle will be placed via the shaft of the epidural needle inserted at the L2-3/L3-4 inter-space by the investigator. After confirming the CSF, 2,5 mg of bupivacaine with 20 µg of fentanyl will be injected. That will be followed by the placement of a 20-gauge multi-hole catheter into the epidural space which will be connected to the PCA pump with a possibility of injecting 6-10 ml 0,1% bupivacaine with 2 µg of fentanyl/ml every 20 min with no background infusion.

干预措施: combined spinal-epidural analgesia (Drug)

结局指标

主要结局

Pain relief with remifentanil or CSE in multiparous women

时间窗: two years

Reduction in visual analog scoring after institution of the respective pain treatments

次要结局

  • Patient satisfaction with pain relief(two years)
  • Duration of first and second stage of labor(one year)

研究者

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

Tatjana Stopar Pintaric

Associate Professor, MD, PhD

University Medical Centre Ljubljana

研究点 (1)

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