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临床试验/NCT07592364
NCT07592364尚未招募不适用

A Randomized Controlled Trial Comparing Efficacy of Programmed Intermittent Epidural Bolus (PIEB) Plus Patient-Controlled Epidural Analgesia (PCEA) Versus Continuous Epidural Infusion (CEI) Plus Patient-Controlled Epidural Analgesia (PCEA) for Labour Analgesia

Aiman Bin Ab Adzim1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1

研究概览

简要总结

During labour process, one of the most effective ways to manage pain is via epidural analgesia. It is commonly and widely use for all pregnant women underwent labour process. It provides good pain relief during labour process especially for contraction pain and pain during descending of baby during delivery.

During epidural insertion, a small catheter (which is flexible and thin) will be inserted via epidural needle at the back. Using this epidural catheter, pain medication will be given to ease and help controlling the pain. This procedure is usually done after you have been admitted to labour room.

In this research, investigator will compare among two different method of epidural administration which are:

- Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia (PIEB +

PCEA):

  • This method will enable the medication to be served automatically within the set time through the epidural catheter and allows for participants to manage additional boluses of medication according to the participants pain level.

- Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia (CEI + PCEA):

  • This method will deliver continuous infusion of medication and allows for participants to manage additional boluses of medication according to the participants pain level.

Investigator want to determine the best method between this two in order to have better pain control, less usage of medication and improving the satisfaction of patient. In participating this research, the participants will help us in understanding the best method to be use for the labour process in which eventually help other future patient who is in need.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • All pregnant female > 36 weeks of gestation
  • Age 18 years old and above
  • ASA I and II
  • Consented for study

排除标准

  • Allergies to LA and opioids
  • Severe systemic and mental disease
  • Contraindication to regional analgesia
  • Hemodynamic instabilities
  • Systemic coagulopathies
  • Treatment with anticoagulants
  • Severe obstetric complications - eg. eclampsia, placenta previae
  • Patient refusal
  • Failed epidural insertion

研究者

发起方
Aiman Bin Ab Adzim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aiman Bin Ab Adzim

Medical officer

Universiti Putra Malaysia

研究点 (1)

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