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临床试验/NCT02809742
NCT02809742已完成不适用

Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study

Pierre and Marie Curie University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年5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
500
试验地点
1
主要终点
Verbal Analogue Satisfaction Score

研究概览

简要总结

Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination.

The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)

详细描述

Patients were explained about the procedure and written informed consent was obtained. Healthy term primi or second gravid parturients (aged >18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia was used.

Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that patients would have a greater level of satisfaction when using PIEB technique. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy term primi or second gravid parturients
  • aged 18-30 years
  • singleton, live fetus
  • vertex presentation
  • active stage of labor with cervical dilation of 3-5 cm parturients

排除标准

  • Hypertension
  • no vertex presentation
  • contraindications to neuraxial blockade

研究组 & 干预措施

Epidural group

Epidural : automatic intermittent boluses ( 8-12 mL per hour) + patient controlled bolus (4 mL evrey 20 min) using ropivacaine

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Verbal Analogue Satisfaction Score

时间窗: 1 day

VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)

次要结局

  • Motor blockade(1 day)
  • fetal heart rate(1 day)
  • maternal hypotension(1 day)
  • Apgar score(1 day)
  • Anesthetic rescue(1 day)
  • nausea(1 day)

研究者

发起方
Pierre and Marie Curie University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Cuvillon

MD, PhD

Centre Hospitalier Universitaire de Nīmes

研究点 (1)

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