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临床试验/NCT00810914
NCT00810914Unknown不适用

Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes

MemorialCare1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2006年3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
发起方
入组人数
270
试验地点
1
主要终点
Total bupivicaine used

研究概览

简要总结

The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.

详细描述

Women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. Each group will initially be given intrathecal bolus. Before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. The continuous epidural infusion group (Group I) will be started immediately on a continuous pump infusion.They will also have the opportunity to give a PCA bolus Finally, the patient controlled epidural group (Group III) will be able to give a bolus every 20 minutes with no continuous infusion. Each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. An hourly evaluation of verbal pain score and maternal mobility will be recorded. After delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Care Provider)

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

  • Early labor
  • Nulliparous

排除标准

  • Inductions
  • Contraindications to regional anesthesia

研究组 & 干预措施

1

Experimental

Continuous epidural infusion of medication for method of pain relief

干预措施: bupivicaine epidural (Drug)

2

Experimental

continuous epidural infusion in conjuction with patient controlled anesthesia (PCA)

干预措施: bupivicaine epidural infusion patient epidural (Drug)

3

Experimental

patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA)

干预措施: bupivicaine (Drug)

结局指标

主要结局

Total bupivicaine used

时间窗: End of labor

次要结局

  • maternal satisfaction(End of labor)

研究者

发起方
MemorialCare
申办方类型
Other

研究点 (1)

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